Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

20429586dft.docx

08/29/23

Formal Meetings

Between the FDA and

Sponsors or Applicants

of PDUFA Products

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 90 days of

publication in the Federal Register of the notice announcing the availability of the draft

guidance. Submit electronic comments to https://www.regulations.gov. Submit written

comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630

Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the

docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact (CDER) Jennifer Mercier at 301-796-0957

or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240-

402-8010.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

September 2023

Procedural

Revision 1

Formal Meetings

Between the FDA and

Sponsors or Applicants

of PDUFA Products

Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

10001 New Hampshire Ave., Hillandale Bldg., 4th Floor

Silver Spring, MD 20993-0002

Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@fda.hhs.gov

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

and/or

Office of Communication, Outreach, and Development

Center for Biologics Evaluation and Research

Food and Drug Administration

10903 New Hampshire Ave., Bldg. 71, Room 3128

Silver Spring, MD 20993-0002

Phone: 800-835-4709 or 240-402-8010; Email: ocod@fda.hhs.gov

https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-

guidances

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

September 2023

Procedural

Revision 1

TABLE OF CONTENTS

I. INTRODUCTION............................................................................................................. 1

II. BACKGROUND ............................................................................................................... 2

III. MEETING TYPES ........................................................................................................... 2

A. Type A Meeting .............................................................................................................................. 2

B. Type B Meeting .............................................................................................................................. 3

C. Type B (EOP) Meeting .................................................................................................................. 3

D. Type C Meeting .............................................................................................................................. 4

E. Type D Meeting .............................................................................................................................. 4

F. INTERACT Meeting ..................................................................................................................... 5

IV. MEETING FORMATS .................................................................................................... 6

V. MEETING REQUESTS ................................................................................................... 6

VI. ASSESSING AND RESPONDING TO MEETING REQUESTS ................................ 9

A. Meeting Denied ............................................................................................................................ 10

B. Meeting Granted .......................................................................................................................... 10

VII. MEETING PACKAGE .................................................................................................. 11

A. Timing of Meeting Package Submission .................................................................................... 12

B. Where and How Many Copies of Meeting Packages to Send .................................................. 12

C. Meeting Package Content ............................................................................................................ 12

VIII. PRELIMINARY RESPONSES ..................................................................................... 14

IX. RESCHEDULING AND CANCELING MEETINGS ................................................ 14

X. MEETING CONDUCT .................................................................................................. 16

XI. MEETING MINUTES.................................................................................................... 16

REFERENCES ............................................................................................................................ 19

APPENDIX: SUMMARY OF MEETING MANAGEMENT PROCEDURAL GOALS ... 20

Contains Nonbinding Recommendations

Draft — Not for Implementation

Formal Meetings Between the FDA and 1

Sponsors or Applicants of PDUFA Products 2

Guidance for Industry

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7

Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8

binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9

applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10

for this guidance as listed on the title page. 11

I. INTRODUCTION 15

This guidance provides recommendations to industry on formal meetings between the Food and 17

Drug Administration (FDA) and sponsors or applicants relating to the development and review 18

of drug or biological drug products (hereafter referred to as products) regulated by the Center for 19

Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research 20

(CBER). This guidance does not apply to abbreviated new drug applications, applications for 21

biosimilar biological products, or submissions for medical devices. For the purposes of this 22

guidance, formal meeting includes any meeting that is requested by a sponsor or applicant 23

(hereafter referred to as requester(s)) following the procedures provided in this guidance and 24

includes meetings conducted in any format (i.e., in person face-to-face, virtual face-to-face 25

(video conference), teleconference, and written response only (WRO) see in section IV, Meeting 26

Formats). 27

This guidance discusses the principles of good meeting management practices and describes 29

standardized procedures for requesting, preparing, scheduling, conducting, and documenting 30

such formal meetings. The general principles in this guidance may be extended to other 31

nonapplication-related meetings with external constituents, insofar as this is possible.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 34

Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 35

as recommendations, unless specific regulatory or statutory requirements are cited. The use of 36

the word should in Agency guidances means that something is suggested or recommended, but 37

not required. 38

This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the

Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.

The guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants (December 2017) and

the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

(June 2018) have been withdrawn.

Contains Nonbinding Recommendations

Draft — Not for Implementation

II. BACKGROUND 41

Each year, FDA review staff participate in many meetings with requesters who seek advice 43

relating to the development and review of investigational new drugs and biologics, and drug or 44

biological product marketing applications. Because these meetings often represent critical points 45

in the drug and biological product development, it is important that there are efficient, consistent 46

procedures for the timely and effective conduct of such meetings. The good meeting 47

management practices in this guidance are intended to provide consistent procedures that will 48

promote well-managed meetings and to ensure that such meetings are scheduled within a 49

reasonable time, conducted efficiently, and documented appropriately. 50

FDA review staff and requesters are expected to adhere to the meeting management goals that 52

were established under reauthorizations of the Prescription Drug User Fee Act (PDUFA).

They 53

are described individually throughout this guidance and summarized in the Appendix. 54

III. MEETING TYPES

There are six types of formal meetings under PDUFA that occur between requesters and FDA 59

staff: Type A, Type B, Type B (end of phase (EOP)), Type C, Type D, and Initial Targeted 60

Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT). 61

A. Type A Meeting 63

Type A meetings are those that are necessary for an otherwise stalled product development 65

program to proceed or to address an important safety issue. Reasons for a Type A meeting 66

include the following: 67

• Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in 69

the guidance for industry and review staff Formal Dispute Resolution: Sponsor Appeals 70

Above the Division Level (November 2017).

• Meetings to discuss clinical holds: (1) in which the requester seeks input on how to 73

address the hold issues; or (2) in which a response to hold issues has been submitted, and 74

See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at

https://www.fda.gov/media/151712/download.

The meeting types and goal dates were negotiated under the Prescription Drug User Fee Act (PDUFA) and apply

to formal meetings between FDA staff and requesters of PDUFA products; they do not apply to meetings with

CDER Office of Generic Drugs, CDER Office of Compliance, or CDER Office of Prescription Drug Promotion.

See the Prescription Drug User Fee Act (PDUFA) web page at

https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.

We update guidances periodically. For the most recent version of a guidance, check the FDA Drugs guidance web

page at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.

Contains Nonbinding Recommendations

Draft — Not for Implementation

reviewed by the FDA, but the FDA and the requester agree that the development is 75

stalled and a new path forward should be discussed. 76

• Meetings that are requested after receipt of an FDA Nonagreement Special Protocol 78

Assessment letter in response to protocols submitted under the special protocol 79

assessment procedures as described in the guidance for industry Special Protocol 80

Assessment (April 2018). 81

• Post-action meetings requested within 3 months after receipt of an FDA regulatory action 83

other than an approval (e.g., issuance of a complete response letter). 84

• Meetings requested within 30 days of FDA issuance of a refuse-to-file letter. To file an 86

application over protest, applicants must first request and have this meeting (21 CFR 87

314.101(a)(3)). 88

B. Type B Meeting 90

Type B meetings are as follows: 92

• Pre-investigational new drug application (pre-IND) meetings. 94

• Pre-emergency use authorization meetings. 96

• Pre-new drug application (pre-NDA)/pre-biologics license application (pre-BLA) 98

meetings (21 CFR 312.47). 99

100

• Post-action meetings requested 3 or more months after receipt of an FDA regulatory 101

action other than an approval (e.g., issuance of a complete response letter, refuse to file). 102

103

• Meetings regarding risk evaluation and mitigation strategies or postmarketing 104

requirements that occur outside the context of the review of a marketing application. 105

106

• Meetings held to discuss the overall development program for products granted 107

breakthrough therapy or regenerative medicine advanced therapy (RMAT) designation 108

status. All subsequent meetings for breakthrough therapy or RMAT-designated products 109

will be considered either Type B or possibly Type A meetings if the meeting request 110

meets the criteria for a Type A meeting. 111

112

C. Type B (EOP) Meeting 113

114

Type B (EOP) meetings are as follows: 115

116

• Certain end-of-phase 1 meetings (i.e., for products that will be considered for marketing 117

approval under 21 CFR part 312, subpart E, or 21 CFR part 314, subpart H, or similar 118

products) 119

120

Contains Nonbinding Recommendations

Draft — Not for Implementation

• End-of-phase 2 (i.e., pre-phase 3) meetings (21 CFR 312.47) 121

122

D. Type C Meeting 123

124

A Type C meeting is any meeting other than a Type A, Type B, Type B (EOP), Type D, or 125

INTERACT meeting regarding the development and review of a product, including meetings to 126

facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never 127

been previously used as the primary basis for product approval in the proposed context of use. 128

129

E. Type D Meeting 130

131

A Type D meeting is focused on a narrow set of issues that are used to discuss issues at key 132

decision points to provide timely feedback critical to move the program forward (e.g., often one, 133

but typically not more than two issues and associated questions). Requests could include the 134

following: 135

136

• A follow-up question that raises a new issue after a formal meeting (i.e., more than just a 137

clarifying question about an FDA response from a prior meeting) 138

139

• A narrow issue on which the sponsor is seeking Agency input with only a few (e.g., three 140

to five questions total) associated questions 141

142

• A general question about an innovative development approach that does not require 143

extensive, detailed advice 144

145

Type D meetings should be limited to no more than two focused topics. If the sponsor has more 146

than two focused topics or a highly complex single issue that includes multiple questions, a Type 147

C meeting should be requested rather than requesting a Type D meeting. A Type C meeting 148

should also be requested when there are more questions than appropriate for a Type D meeting. 149

Sponsors should not request several Type D meetings in temporal proximity instead of a single 150

Type C meeting. In addition, the issue should not require input from more than three disciplines 151

or divisions. If the scope of the meeting is broad or includes complex questions/issues that 152

require input from more than three disciplines or divisions, or requires cross-center responses, or 153

additional regulatory review, then FDA will inform the sponsor that the Agency will be 154

converting the meeting to the appropriate meeting type (Type B or C) and the sponsor can either 155

withdraw their request or accept the FDA’s meeting-type conversion without resubmitting a new 156

meeting request. 157

158

Examples and Scenarios 159

160

• A sponsor has a specific question about an aspect of a complex or innovative trial design 161

(e.g., innovative pediatric design approach) 162

163

• A sponsor has a specific question about presenting data following a pre-BLA/NDA 164

meeting 165

166

Contains Nonbinding Recommendations

Draft — Not for Implementation

• A sponsor has a specific follow-up question about a new idea stemming from a Type C 167

meeting 168

169

170

F. INTERACT Meeting 171

172

INTERACT meetings are intended for novel products and development programs that present 173

unique challenges in early development (i.e., before filing of an IND or before having a pre-IND 174

meeting). The issues typically relate to IND requirements, for example, questions about design 175

of IND-enabling toxicity studies (e.g., species, endpoints), complex manufacturing technologies 176

or processes, development of innovative devices used with a drug or biologic, or the use of New 177

Approach Methodologies. INTERACT meetings are intended to facilitate IND-enabling efforts 178

when the sponsor is facing a novel, challenging issue that might otherwise delay progress of the 179

product toward entry into the clinic in the absence of this early FDA input. The sponsor needs to 180

have selected a specific investigational product or a product-derivation strategy to evaluate in a 181

clinical study before requesting an INTERACT meeting. 182

183

Questions and topics within the scope of an INTERACT meeting include the following: 184

185

• Questions for novel products and development programs that present unique challenges 186

in early development for all CDER and CBER products (i.e., questions for which there is 187

no existing guidance or other information in writing the company could reference from 188

FDA). 189

190

• Issues that a sponsor needs to address before a pre-IND meeting, including issues such as 191

the following: 192

193

– Choice of appropriate preclinical models or necessary toxicology studies for novel 194

drug platforms or drug candidates 195

196

– Chemistry, manufacturing, and controls issues or testing strategies aimed to 197

demonstrate product safety adequate to support first-in-human study 198

199

– Overall advice related to the design of proof-of-concept or other pilot 200

safety/biodistribution studies necessary to support administration of an investigational 201

product in a first-in-human clinical trial 202

203

– General recommendations about a future first-in-human trial in a target clinical 204

population for which the population is novel and there is no prior precedent or 205

guidance 206

207

– Recommendations on approach for further development of an early-stage product 208

with limited chemistry, manufacturing, and controls; pharmacology/toxicology; 209

and/or clinical data that were collected outside of a U.S. IND 210

211

– Other topics that would be agreed upon by FDA 212

Contains Nonbinding Recommendations

Draft — Not for Implementation

213

214

215

IV. MEETING FORMATS 216

217

There are four meeting formats: In person face-to-face, virtual face-to-face, teleconference, and 218

WRO, as follows: 219

220

1. In person face-to-face — Core attendees

from the FDA and the sponsor/applicant 221

participate in person at the FDA; such meetings will be hybrid with a virtual component 222

to allow non-core participants to join virtually. Because the intent is that the primary 223

discussion occurs face-to-face in person, all sponsors and FDA individuals who are key 224

to such discussions (i.e., “core” attendees) should participate, if at all feasible, in person. 225

Individuals expected to have a more peripheral role (e.g., may be called on to comment 226

on a single question) may participate virtually. If core sponsor personnel are suddenly 227

unable to attend the in person meeting due to illness or unexpected travel issues, they can 228

join the meeting virtually. If core sponsor personnel are not planning to attend in person, 229

the meeting should be requested as a virtual face-to-face meeting. 230

231

2. Virtual face-to-face (video conference) — Attendees participate remotely via virtual 232

meeting platform (e.g., Zoom) (with core attendees’ cameras on). 233

234

3. Teleconference — Attendees participate via an audio only connection (e.g., telephone, 235

virtual meeting platform without cameras on). 236

237

4. Written Response Only (WRO) — Written responses are sent to requesters in lieu of 238

meetings conducted in one of the other formats described above. 239

240

241

V. MEETING REQUESTS 242

243

To make the most efficient use of FDA resources, requesters should use the extensive sources of 244

product development information that are publicly available before seeking a meeting (e.g., 245

guidances). To disseminate a broad range of information in a manner that can be easily and 246

rapidly accessed by interested parties, the FDA develops and maintains web pages, portals, and 247

databases, and participates in interactive media as a means of providing information on scientific 248

and regulatory issues. 249

250

To promote efficient meeting management, requesters should try to anticipate future needs and, 251

to the extent practical, address relevant and related product development issues in the fewest 252

possible meetings while avoiding meetings with too many questions (or subparts of questions) 253

that would be impractical to discuss in the context of any single meeting. Furthermore, having 254

FDA will have its core participants with a primary speaking roles participate in person while others may join

virtually (see https://www.fda.gov/industry/prescription-drug-user-fee-amendments/update-person-face-face-formal-

meetings-fda).

Contains Nonbinding Recommendations

Draft — Not for Implementation

too many questions is not recommended when the topics are complex or if the combined issues 255

would involve voluminous material for FDA review. As discussed below, there should generally 256

be no more than 10 total questions to the FDA. 257

258

When a meeting is needed, a written request must be submitted to the FDA via the electronic 259

gateway or, in CDER, via the CDER Nextgen Portal, as appropriate.

For additional ways to 260

submit to CBER, please see https://www.fda.gov/about-fda/about-center-biologics-evaluation-261

and-research-cber/regulatory-submissions-electronic-and-paper. Requests should be addressed 262

to the appropriate Center and review division or office and, if previously assigned, submitted to 263

the application (e.g., investigational new drug application (IND), new drug application (NDA), 264

biologics license application (BLA), pre-application tracking system (PTS) Number (CBER)). If 265

necessary, noncommercial IND holders may also submit the meeting request via the appropriate 266

center’s document room. 267

268

The meeting request should include adequate information for the FDA to assess the potential 269

utility of the meeting and to identify FDA staff necessary to discuss proposed agenda items. 270

271

The meeting request should include the following information: 272

273

1. The application number (if previously assigned). 274

275

2. The product name. 276

277

3. The chemical name, established name, and/or structure. 278

279

4. The proposed regulatory pathway (e.g., 505(b)(1), 505(b)(2)). 280

281

5. The proposed indication(s) or context of product development. 282

283

6. The meeting type being requested (i.e., Type A, Type B, Type B (EOP), Type C, Type D, 284

or INTERACT). 285

286

7. Pediatric study plans, if applicable. 287

288

8. Human factors engineering plan, if applicable. 289

290

9. Combination product information (e.g., constituent parts, including details of the device 291

constituent part, intended packaging, planned human factors studies), if applicable. 292

293

10. Suggested dates and times (e.g., morning or afternoon) for the meeting that are consistent 294

with the appropriate scheduling time frame for the meeting type being requested (see 295

Table 2 in section VI.B., Meeting Granted). Dates and times when the requester is not 296

available should also be included. 297

298

See the guidance for industry Providing Regulatory Submissions in Electronic Format — Submissions Under

Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (December 2014).

Contains Nonbinding Recommendations

Draft — Not for Implementation

11. A list of proposed questions, grouped by FDA discipline. For each question there should 299

be a brief explanation of the context and purpose of the question. 300

301

The meeting request must include the following information:

302

303

1. The proposed meeting format (i.e., in person face-to-face, virtual face-to-face, 304

teleconference, and WRO (see section IV, Meeting Formats)). 305

306

2. The date the meeting package will be sent by the requester (see section VII.A., Timing of 307

Meeting Package Submission). Meeting packages should be included with the meeting 308

request for all Type A meetings, Type C meetings where the objective is to facilitate 309

early consultation on the use of a biomarker as a new surrogate endpoint that has never 310

been previously used as the primary basis for product approval in the proposed context of 311

use, all Type D meetings, and all INTERACT meetings. 312

313

3. A brief statement of the purpose of the meeting that should include a background of the 314

issues underlying the agenda and a summary of completed or planned studies and clinical 315

trials or data that the requester intends to discuss at the meeting. The statement should 316

then include a description of the general issues being raised of the questions to be asked 317

and where the meeting fits in overall development plans. Although the statement should 318

not provide the details of trial designs or completed studies and clinical trials, it should 319

provide enough information to facilitate understanding of the issues, such as a small table 320

that summarizes major results that are necessary to provide the FDA an understanding of 321

the questions to be addressed at the meeting. 322

323

4. A proposed agenda, including estimated time needed for discussion of each agenda item. 324

325

5. A list of planned attendees from the requester’s organization, including their names and 326

titles. The list should also include the names, titles, and affiliations of consultants and 327

interpreters, if applicable. 328

329

6. A list of requested FDA attendees and/or discipline representative(s). Requests for 330

attendance by FDA staff who are not otherwise essential to the application’s review may 331

affect the ability to hold the meeting within the specified time frame of the meeting type 332

being requested. Therefore, when attendance by nonessential FDA staff is requested, the 333

meeting request should provide a justification for such attendees and state whether a later 334

meeting date is acceptable to the requester to accommodate the nonessential FDA 335

attendees. 336

337

A well-written meeting request that includes the above components can help the FDA understand 338

and assess the utility and timing of the meeting related to product development or review. The 339

list of requester attendees and the list of requested FDA attendees can be useful in providing or 340

preparing for the input needed at the meeting. However, during the time between the request and 341

the meeting, the planned attendees can change. Therefore, an updated list of attendees with their 342

See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at

https://www.fda.gov/media/151712/download.

Contains Nonbinding Recommendations

Draft — Not for Implementation

titles and affiliations should be included in the meeting package and a final list provided to the 343

appropriate FDA contact before the meeting (see section VII.C., Meeting Package Content). 344

345

The objectives and agenda provide overall context for the meeting topics, but it is the list of 346

questions that is most critical to understanding the kind of information or input needed by the 347

requester, whether or not the questions can be feasibly addressed within the time frame 348

associated with the meeting type requested, and to focus the discussion should the meeting be 349

granted. Each question should be precise and include a brief explanation of the context and 350

purpose of the question. The questions submitted within a single meeting request should be 351

limited to those that can be reasonably answered within the allotted meeting time, taking into 352

consideration the complexity of the questions submitted. Similar considerations about the 353

complexity of questions submitted within a WRO should be applied. In general, there should be 354

no more than 10 questions listed consecutively regardless of discipline. The FDA requests that 355

meeting requesters not submit subquestions, as they will be counted toward the overall number 356

of questions. For example, if Question 1 has three parts, the numbering should be 1, 2, and 3 357

rather than numbering them 1a, 1b, and 1c (i.e., with each as “subquestions”). If there are three 358

clinical questions and three nonclinical questions, for a total of six questions, each question 359

should have its own number (i.e., 1, 2, 3, 4, 5, 6, not Clinical 1, 2, 3 and then Nonclinical 1, 2, 3). 360

The numbering of each question in the meeting request (see section VI, Assessing and 361

Responding to Meeting Requests) should be identical to the numbering of each question in the 362

meeting package. 363

364

365

VI. ASSESSING AND RESPONDING TO MEETING REQUESTS 366

367

For any type of meeting, the sponsor may request a WRO to its questions rather than another 368

meeting format. The FDA will review the request and make a determination on whether a WRO 369

is appropriate or whether an in person face-to-face, virtual face-to-face, teleconference, or WRO 370

(see section IV., Meeting Formats) meeting is necessary. If a written response is requested and 371

deemed appropriate, the FDA will notify the requester of the date it intends to send the written 372

response in the Agency’s response to the meeting request. 373

374

For pre-IND, Type C, Type D, and INTERACT meetings, although the sponsor may request an 375

in-person, virtual, or teleconference meeting, the Agency may determine that a written response 376

to the sponsor’s questions would be the most appropriate means for providing feedback and 377

advice to the sponsor. When it is determined that the meeting request can be appropriately 378

addressed through a written response, the FDA will notify the requester of the date it intends to 379

send the written response in the Agency’s response to the meeting request. If the sponsor 380

believes a meeting is needed, the sponsor may provide a rationale in a follow-up correspondence 381

to the division, explaining their rationale for the meeting. The FDA will consider the follow-up 382

correspondence and may or may not convert the WRO back to an appropriate format. 383

384

Requests for Type B and Type B (EOP) meetings will be honored if the sponsor is at the 385

appropriate stage of development to make such a meeting productive. For example, a request for 386

an EOP2 meeting should clearly describe the status of the phase 2 trial(s) and whether summary 387

efficacy and safety data from these trial(s) will be available in the briefing document, as the lack 388

Contains Nonbinding Recommendations

Draft — Not for Implementation

of these data will render an EOP2 meeting request premature. With the exception of products 389

granted breakthrough therapy or RMAT designation status, the FDA generally will not grant 390

more than one of each of the Type B meetings for each potential application (e.g., IND, NDA, 391

BLA) or combination of closely related products developed by the same requester (e.g., same 392

active ingredient but different dosage forms being developed concurrently), but the FDA can do 393

so when it would be beneficial to hold separate meetings to discuss unrelated issues. For 394

example, it may be appropriate to conduct more than one end-of-phase 2 meeting with different 395

review divisions or disciplines for concurrent development of a product for unrelated claims or a 396

separate meeting to discuss manufacturing development when the clinical development is on a 397

different timeline. For novel programs, with many complex issues, discussion with the relevant 398

division may lead to an agreement that additional meetings are needed. 399

400

A. Meeting Denied 401

402

If a meeting request is denied, the FDA will notify the requester in writing according to the 403

timelines described in Table 1. The FDA’s letter will include an explanation of the reason for 404

the denial. Denials will be based on a substantive reason, not merely on the absence of a minor 405

element of the meeting request or meeting package items. For example, a meeting can be denied 406

because it is premature for the stage of product development or because the meeting package 407

does not provide an adequate basis for the meeting discussion (see section IX., Rescheduling and 408

Canceling Meetings, for the effect of inadequate meeting packages on other meeting types when 409

the package is received after the meeting is granted). The FDA may also deny requests for 410

meetings that do not have substantive required elements described in section V., Meeting 411

Requests. A subsequent request to schedule the meeting will be considered as a new request 412

(i.e., a request that merits a new set of time frames as described in section below, Meeting 413

Granted). 414

415

B. Meeting Granted 416

417

If a meeting request is granted, the FDA will notify the requester in writing according to the 418

timelines described in Table 1. For in person face-to-face, virtual face-to-face, and 419

teleconference meetings, the FDA’s letter will include the date, time, conferencing arrangements, 420

and/or location of the meeting, as well as expected FDA participants. For WRO requests, the 421

FDA’s letter will include the date the FDA intends to send the written responses (see Table 3 for 422

FDA WRO response timelines). As shown in Tables 2 and 3, FDA WRO response timelines are 423

the same as those for scheduling an in-person face-to-face, virtual face-to-face, or teleconference 424

meeting of the same meeting type. 425

426

For in person face-to-face, virtual face-to-face, and teleconference meetings, the FDA will 427

schedule the meeting on the available date at which all expected FDA staff are available to 428

attend; however, the meeting should be scheduled consistent with the type of meeting requested 429

(see Table 2 for FDA meeting scheduling time frames). If the requestor’s requested date for any 430

meeting type is greater than the specified time frame, the meeting date should be scheduled by 431

the FDA within 14 calendar days of that requested date. 432

433

434

Contains Nonbinding Recommendations

Draft — Not for Implementation

Table 1. FDA Meeting Request/WRO Request Response Timelines 435

Meeting Type

(any format)

Response Time

(calendar days from receipt of

meeting request/WRO request)

14 days

21 days

B (EOP)

14 days

21 days

14 days

INTERACT

21 days

436

Table 2. FDA Meeting Scheduling Time Frames 437

Meeting Type

Meeting Scheduling

(calendar days from receipt of

meeting request)

30 days

60 days

B (EOP)

70 days

75 days

50 days

INTERACT

75 days

438

Table 3. FDA WRO Response Timelines 439

Meeting Type

WRO Response Time

(calendar days from receipt of

WRO request)

30 days

60 days

B (EOP)

70 days

75 days

50 days

INTERACT

75 days

440

441

VII. MEETING PACKAGE 442

443

Premeeting preparation is critical for achieving a productive discussion or exchange of 444

information. Preparing the meeting package should help the requester focus on describing its 445

principal areas of interest. The meeting package should provide information relevant to the 446

discussion topics and enable the FDA to prepare adequately for the meeting. In addition, the 447

timely submission of the meeting package is important for ensuring that there is sufficient time 448

for meeting preparation, accommodating adjustments to the meeting agenda, and accommodating 449

appropriate preliminary responses to meeting questions. Requestors are encouraged to include 450

their meeting package for all meeting types, if possible, but must meet the required due dates for 451

certain meetings (see Table 4 below). 452

453

Contains Nonbinding Recommendations

Draft — Not for Implementation

A. Timing of Meeting Package Submission 454

455

Requesters must submit the meeting package for each meeting type (including WRO) according 456

to the meeting package timelines described in Table 4.

457

458

Table 4. Requester Meeting Package Timelines 459

Meeting

Type

FDA Receipt of Meeting Package (calendar days)

A, C*, D,

INTERACT

At the time of the meeting request

No later than 30 days before the scheduled date of the meeting

or WRO response time

B (EOP)

No later than 50 days before the scheduled date of the meeting

or WRO response time**

No later than 47 days before the scheduled date of the meeting

or WRO response time***

*For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as 460

the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the 461

meeting request. 462

** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request, 463

the requester’s meeting package will be due no sooner than 6 calendar days after FDA response time for issuing the 464

letter granting the meeting (see Table 1 in section VI.B., Meeting Granted). 465

*** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the 466

meeting package will be due no sooner than 7 calendar days after FDA response time for issuing the letter granting 467

the meeting (see Table 1 in section VI.B., Meeting Granted). 468

469

B. Where and How Many Copies of Meeting Packages to Send 470

471

Requesters should submit the archival meeting package to the relevant application(s) (e.g., pre-472

IND, IND, NDA, BLA or PTS (CBER)) via the electronic gateway or, in CDER, via the CDER 473

Nextgen Portal (https://cdernextgenportal.fda.gov/), as applicable.

For additional ways to 474

submit to CBER, please see https://www.fda.gov/about-fda/about-center-biologics-evaluation-475

and-research-cber/regulatory-submissions-electronic-and-paper. If necessary, noncommercial 476

IND holders may also submit the package via the appropriate center’s document room. 477

478

C. Meeting Package Content 479

480

The meeting package should provide summary information relevant to the product and any 481

supplementary information needed to develop responses to issues raised by the requester or 482

review division. It is critical that the entire meeting package content support the intended 483

meeting objectives. The meeting package content will vary depending on the product, 484

indication, phase of product development, and issues to be discussed. FDA and ICH guidances 485

See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at

https://www.fda.gov/media/151712/download.

See the guidances for industry Providing Regulatory Submissions in Electronic Format — Submissions Under

Section 745A(a) of the Federal Food, Drug, and Cosmetic Act and Providing Regulatory Submissions in Electronic

Format — General Considerations (January 1999).

Contains Nonbinding Recommendations

Draft — Not for Implementation

identify and address many issues related to product development and should be considered when 486

planning, developing, and providing information needed to support a meeting with the FDA. If a 487

product development plan deviates from current guidances, or from existing precedent, the 488

deviation should be identified and explained. Known difficult design and questions about 489

providing substantial evidence of effectiveness should be raised for discussion (e.g., use of a 490

surrogate endpoint, reliance on a single study, use of a noninferiority design, adaptive designs). 491

Also, merely describing a result as significant does not provide the review division with enough 492

information to give the most constructive advice or identify important problems the requester 493

may have missed. 494

495

To facilitate FDA review, the meeting package content should be organized according to the 496

proposed agenda. The meeting package should be a sequentially paginated document with a 497

table of contents with appropriate electronic linkage, appropriate indices, appendices, and cross 498

references. It should enhance reviewers’ navigation across different sections within the package, 499

both in preparation for and during the meeting. Meeting packages generally should include the 500

following information, preferably in the order listed below: 501

502

Meeting packages should include the same first nine items provided for the meeting request (see 503

above section V.), and in addition, should include: 504

505

1. A list of all individuals, with their titles and affiliations, who will attend the requested 506

meeting from the requester’s organization, including consultants and interpreters. 507

508

2. A background section that includes the following: 509

510

a. A brief history of the development program and relevant communications with the 511

FDA before the meeting 512

513

b. Substantive changes in product development plans (e.g., new indication, population, 514

basis for a combination), when applicable 515

516

c. The current status of product development (e.g., drug development plan) 517

518

3. A brief statement summarizing the purpose of the meeting and identifying the type of 519

meeting, if applicable. 520

521

4. A proposed agenda, including estimated time needed for discussion of each agenda item. 522

523

5. A list of the final questions for discussion grouped by FDA discipline and with a brief 524

summary for each question to explain the need or context for the question. 525

526

6. Data to support discussion organized by FDA discipline and question. Protocols, full 527

study reports, or detailed data generally are not appropriate for meeting packages; the 528

summarized material should describe the results of relevant studies and clinical trials with 529

some degree of quantification and any conclusion about clinical trials that resulted. The 530

Contains Nonbinding Recommendations

Draft — Not for Implementation

trial endpoints should be stated, as should whether endpoints were altered or analyses 531

changed during the course of the trial. 532

533

For example, for an end-of-phase 2 meeting, this section of the meeting package should 534

include the following: A description and the results of controlled trials conducted to 535

determine dose-response information, summary efficacy and safety data from the phase 2 536

trial(s); adequately detailed descriptors of planned phase 3 trials identifying major trial 537

features such as population, critical exclusions, trial design (e.g., randomization, blinding, 538

and choice of control group, with an explanation of the basis for any noninferiority 539

margin if a noninferiority trial is used), dose selection, and primary and secondary 540

endpoints; and major analyses (including planned interim analyses and adaptive features, 541

and major safety concerns). 542

543

544

VIII. PRELIMINARY RESPONSES 545

546

Communications before the meeting between requesters and the FDA, including preliminary 547

responses, can serve as a foundation for discussion or as the final meeting responses. 548

Preliminary responses should not be construed as final unless there is agreement between the 549

requester and the FDA that additional discussion is not necessary for any question (i.e., when the 550

meeting is canceled because the responses and comments are clear to the requester), or a 551

particular question is considered resolved allowing extra time for discussion of the more 552

complex questions during the meeting. Preliminary responses communicated by the FDA are not 553

intended to generate the submission of new information or new questions. If a requester 554

nonetheless provides new data or a revised or new proposal, the FDA may not be able to provide 555

comments on the new information, or it may necessitate the submission of a new meeting request 556

by the requester. 557

558

The FDA holds an internal meeting to discuss the content of meeting packages and to gain 559

internal alignment on the preliminary responses. The FDA will send the requester its 560

preliminary responses to the questions in the meeting package no later than 5 calendar days 561

before the meeting date for Type B (EOP), Type C, Type D, and INTERACT meetings. The 562

requester will notify the FDA no later than 3 calendar days following receipt of the FDA’s 563

preliminary responses for these meeting types of whether the meeting is still needed, and if it is, 564

the requester will send the FDA a revised meeting agenda indicating which questions the 565

requestor considers as resolved and which questions the requestor will want to further discuss 566

within the allotted time as reasonable.

For Type A and Type B (other than Type B (EOP)), the 567

FDA intends to send the requester its preliminary responses no later than 2 calendar days before 568

the meeting. 569

570

571

IX. RESCHEDULING AND CANCELING MEETINGS 572

573

See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at

https://www.fda.gov/media/151712/download.

Contains Nonbinding Recommendations

Draft — Not for Implementation

Occasionally, circumstances arise that necessitate rescheduling or canceling a meeting. If a 574

meeting needs to be rescheduled, it should be rescheduled as soon as possible after the original 575

date. A new meeting request should not be submitted. However, if a meeting is canceled, the 576

FDA will consider a subsequent request to schedule a meeting to be a new request (i.e., a request 577

that merits a new set of time frames as described in section VI., Assessing and Responding to 578

Meeting Requests). Requesters and the FDA should take reasonable steps to avoid rescheduling 579

and canceling meetings (unless the meeting is no longer necessary). For example, if an attendee 580

becomes unavailable, a substitute can be identified, or comments on the topic that the attendee 581

would have addressed can be forwarded to the requester following the meeting. It will be at the 582

discretion of the review division whether the meeting should be rescheduled or canceled 583

depending on the specific circumstances. 584

585

The following situations are examples of when a meeting can be rescheduled. Some of the 586

examples listed also represent reasons that a meeting may be canceled by the FDA. This list 587

includes representative examples and is not intended to be an exhaustive list. 588

589

• The requester experiences any delay in submitting the meeting package. The requester 590

should contact the FDA project manager to explain why it cannot meet the time frames 591

for submission and when the meeting package will be submitted. 592

593

• The review team determines that the meeting package is inadequate, or additional 594

information is needed to address the requester’s questions or other important issues for 595

discussion, but it is possible to identify the additional information needed and arrange for 596

its timely submission. 597

598

• There is insufficient time to review the material because the meeting package is 599

voluminous (see section VII.C., Meeting Package Content), despite submission within the 600

specified time frames and the appropriateness of the content. 601

602

• After the meeting package is submitted, the requester sends the FDA additional questions 603

or data that are intended for discussion at the meeting and require additional review time. 604

605

• It is determined that attendance by additional FDA personnel not originally anticipated or 606

requested is critical and their unavailability precludes holding the meeting on the original 607

date. 608

609

• Essential attendees are no longer available for the scheduled date and time because of an 610

unexpected or unavoidable conflict or an emergency situation. 611

612

The following situations are examples of when a meeting can be canceled: 613

614

• The meeting package is not received by the FDA within the specified time frames (see 615

section VII.A., Timing of Meeting Package Submission) or is grossly inadequate. 616

Meetings are scheduled on the condition that appropriate information to support the 617

discussion will be submitted with sufficient time for review and preparatory discussion. 618

Adequate planning should avoid this problem. 619

Contains Nonbinding Recommendations

Draft — Not for Implementation

620

• The requester determines that preliminary responses to its questions are sufficient for its 621

needs and additional discussion is not necessary (see section VIII., Preliminary 622

Responses). In this case, the requester should contact the FDA project manager to 623

request cancellation of the meeting. The FDA will consider whether it agrees that the 624

meeting should be canceled. Some meetings, particularly milestone meetings, can be 625

valuable because of the broad discussion they generate and the opportunity for the 626

division to ask about relevant matters (e.g., dose-finding, breadth of subject exposure, 627

particular safety concerns), even if the preliminary responses seem sufficient to answer 628

the requester’s questions. If the FDA agrees that the meeting can be canceled, the reason 629

for cancellation will be documented and the preliminary responses will represent the final 630

responses and the official record. 631

632

633

X. MEETING CONDUCT 634

635

Meetings will be chaired by an FDA staff member and begin with introductions and an overview 636

of the agenda. FDA policy prohibits audio or visual recording of discussions at meetings. 637

638

Presentations by requesters are usually unnecessary because the information necessary for 639

review and discussion should be part of the meeting package. If a requester plans to make a 640

presentation, the presentation materials should be provided ahead of the meeting. All 641

presentations should be kept brief to maximize the time available for discussion. The length of 642

the meeting will not be increased to accommodate a presentation. If a presentation contains 643

more than a small amount of content distinct from clarifications or explanations of previous data 644

and that were not included in the original meeting package submitted for review, FDA staff may 645

not be able to provide commentary. 646

647

Either a representative of the FDA or the requester should summarize the important discussion 648

points, agreements, clarifications, and action items. Summation can be done at the end of the 649

meeting or after the discussion of each question. Generally, the requester will be asked to 650

present the summary to ensure that there is mutual understanding of meeting outcomes and 651

action items. FDA staff can add or further clarify any important points not covered in the 652

summary, and these items can be added to the meeting minutes. At pre-NDA and pre-BLA 653

meetings for applications reviewed under the PDUFA Program for Enhanced Review 654

Transparency and Communication for New Molecular Entity (NME) NDAs and Original BLAs 655

(also known as the Program),

the requester and the FDA should also summarize agreements 656

regarding the content of a complete application and any agreements reached on delayed 657

submission of certain minor application components. 658

659

660

XI. MEETING MINUTES 661

662

Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of 663

meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this 664

See https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm.

Contains Nonbinding Recommendations

Draft — Not for Implementation

information is preserved for meeting attendees and future reference. The FDA will issue the 665

official, finalized minutes to the requester within 30 calendar days after the meeting. 666

667

The following are general considerations regarding meeting minutes: 668

669

• FDA minutes will outline the important agreements, disagreements, issues for further 670

discussion, and action items from the meeting in bulleted format. The minutes should be 671

sufficiently detailed that they provide clarity about the agreements, such as on study 672

design elements, or statistical testing, or enrollment criteria and similar important areas of 673

the development program. The minutes are not intended to represent a transcript of the 674

meeting. 675

676

• FDA project managers will use established templates to ensure that all important meeting 677

information is captured. 678

679

• The FDA may communicate additional information in the final minutes that was not 680

explicitly communicated during the meeting (e.g., pediatric requirements, data standards, 681

abuse liability potential) or that provides further explanation of discussion topics. The 682

FDA’s final minutes will distinguish this additional information from the discussion that 683

occurred during the meeting. 684

685

• For INTERACT meetings, preliminary responses will be annotated and resent within 30 686

days if advice provided changes as a result of the meeting. 687

688

• In cases of a WRO, the WRO will serve as meeting minutes. 689

690

The following steps should be taken when there is a difference of understanding regarding the 691

minutes: 692

693

• Requesters should contact the FDA project manager if there is a significant difference in 694

their and the FDA’s understanding of the content of the final meeting minutes issued to 695

the requesters 696

697

• If after contacting the FDA project manager there are still significant differences in the 698

understanding of the content, the requester should submit a description of the specific 699

disagreements either: 700

701

‒ To the application; or 702

703

‒ If there is no application, in a letter to the division director, with a copy to the FDA 704

project manager 705

706

• The review division and the office director, if the office director was present at the 707

meeting, will take the concerns under consideration 708

709

Contains Nonbinding Recommendations

Draft — Not for Implementation

‒ If the minutes are deemed to accurately and sufficiently reflect the meeting 710

discussion, the FDA project manager will convey this decision to the requester and 711

the minutes will stand as the official documentation of the meeting. 712

713

‒ If the FDA deems it necessary, changes will be documented in an addendum to the 714

official minutes. The addendum will also document any remaining requester 715

objections, if any. 716

717

For input on additional issues that were not addressed at the meeting, the requester should submit 718

a new meeting request, a WRO request, or a submission containing specific questions for FDA 719

feedback. 720

721

For all meeting types, to ensure the sponsor’s understanding of FDA feedback from meeting 722

discussions or a WRO, sponsors may submit a “follow-up opportunity/clarifying questions” 723

correspondence to the agency in a formal submission to their application. Only questions of a 724

clarifying nature should be submitted (i.e., to confirm something in minutes or in a WRO issued 725

by the FDA) rather than new issues or new proposals. If the FDA determines that the requests 726

are not in scope (i.e., are not simply clarifications of advice provided at the meeting), the division 727

may advise the sponsor to request a new meeting to address the issue. However, if the out-of-728

scope issue is narrow and focused, the review division, at their discretion, may provide a 729

response (as a general correspondence) as soon as reasonably possible. The clarifying questions 730

should be sent in writing as a “Request for Clarification” to the FDA within 20 calendar days 731

following receipt of the meeting minutes or WRO, to include if the preliminary comments serve 732

as the final minutes for a cancelled meeting. For questions that meet the criteria, the FDA will 733

issue a response in writing within 20 calendar days of receipt of the clarifying questions. The 734

FDA’s response will reference the original minutes or WRO. 735

736

Contains Nonbinding Recommendations

Draft — Not for Implementation

REFERENCES 737

738

Related Guidances

739

740

Guidance for industry and review staff Best Practices for Communication Between IND 741

Sponsors and FDA During Drug Development (December 2017) 742

743

Guidance for review staff and industry Good Review Management Principles and Practices for 744

PDUFA Products (April 2005) 745

746

Related CDER MAPP

747

748

MAPP 6025.6 Good Review Practice: Management of Breakthrough Therapy-Designated 749

Drugs and Biologics 750

751

Related CBER SOPPs

752

753

SOPP 8101.1 Regulatory Meetings With Sponsors and Applicants for Drugs and Biological 754

Products 755

756

SOPP 8404.1 Procedures for Filing an Application When the Applicant Protests a Refusal to 757

File Action (File Over Protest) 758

759

Guidances can be found on the FDA Drugs guidance web page at

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

MAPPs can be found on the CDER Manual of Policies and Procedures web page at

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProc

edures/default.htm.

SOPPs can be found on the Biologics Procedures (SOPPs) web page at

https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/defau

lt.htm.

Contains Nonbinding Recommendations

Draft — Not for Implementation

APPENDIX: 760

SUMMARY OF MEETING MANAGEMENT PROCEDURAL GOALS 761

762

Table A is a summary of Prescription Drug User Fee Act meeting management procedural goals. 763

764

Table A. Meeting Management Procedural Goals 765

Meeting

Type

FDA

Response

Request

FDA

Receipt of

Meeting

Package

FDA

Preliminary

Responses to

Requester (if

applicable†)

Requester

Response to

FDA

Preliminary

Responses (if

applicable†)

FDA

Scheduled

Meeting

Date (days

from receipt

of request)

FDA

Meeting

Minutes to

Requester

(if

applicable†)

14 days

With

meeting

request

No later than

2 days before

meeting

Within 30

days

30 days after

meeting

21 days

No later

than 30

days before

meeting

No later than

2 days before

meeting

Within 60

days

30 days after

meeting

(EOP)*

14 days

No later

than 50

days before

meeting**

No later than

5 days before

meeting

No later than 3

days after

receipt of

preliminary

responses

Within 70

days

30 days after

meeting

21 days

No later

than 47

days before

meeting***

No later than

5 days before

meeting

No later than 3

days after

receipt of

preliminary

responses

Within 75

days

30 days after

meeting

14 days

With

meeting

request

No later than

5 days before

meeting

No later than 3

days after

receipt of

preliminary

responses

Within 50

days

30 days after

meeting

INTERA

21 days

With

meeting

request

No later than

5 days before

the meeting

No later than 3

days after

receipt of

preliminary

responses

Within 75

days

Preliminary

responses

annotated 30

days after

meeting

† Not applicable to written response only. 766

* EOP = end of phase. 767

Contains Nonbinding Recommendations

Draft — Not for Implementation

** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request,

768

the requester’s meeting package will be due no sooner than 6 calendar days after FDA response time for issuing the 769

letter granting the meeting (see Table 1 in section VI.B., Meeting Granted). 770

*** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the 771

meeting package will be due no sooner than 7 calendar days after FDA response time for issuing the letter granting 772

the meeting (see Table 1 in section VI.B., Meeting Granted). For Type C meetings that are requested as early 773

consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a 774

proposed context of use, the meeting package is due at the time of the meeting request. 775