Guidance for Industry 

Formal Meetings Between the 

FDA and Sponsors or 

Applicants 

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) 

May 2009 

Procedural 

Revision 1 
Guidance for Industry 

Formal Meetings Between the 

FDA and Sponsors or 

Applicants 

Additional copies are available from: 

Office of Communications 

Division of Drug Information 

Center for Drug Evaluation and Research 

Food and Drug Administration 

10903 New Hampshire Ave., Bldg. 51, rm. 2201 

Silver Spring, MD 20993-0002 

E-mail: druginfo@fda.hhs.gov 

Fax: 301-847-8714 

(Tel) 301-796-3400 

http://www.fda.gov/cder/guidance/index.htm 

or 

Office of Communication, 

Outreach, and Development, HFM-40 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

1401 Rockville Pike, Rockville, MD 20852-1448 

(Tel) 800-835-4709 or 301-827-1800

http://www.fda.gov/cber/guidelines.htm 

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) 

May 2009 

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 C Meeting..............................................................................................................................3

IV. MEETING REQUESTS BY SPONSORS OR APPLICANTS..................................... 4

V. ASSESSING MEETING REQUESTS............................................................................ 5

A. Meeting Denied ..............................................................................................................................5

B. Meeting Granted ............................................................................................................................5

VI. RESCHEDULING AND CANCELLING MEETINGS................................................ 6

VII. MEETING PACKAGE CONTENT AND SUBMISSION............................................ 7

A. Timing of Submission ....................................................................................................................7

B. Where and How Many Copies of Meeting Packages to Send ....................................................8

C. Meeting Package Content..............................................................................................................8

VIII. PREMEETINGS AND COMMUNICATIONS WITH SPONSORS OR 

APPLICANTS................................................................................................................... 9

IX. PROCEDURES FOR THE CONDUCT OF MEETINGS............................................ 9

X. DOCUMENTATION OF MEETINGS......................................................................... 10

XI. RESOLUTION OF DISPUTE ABOUT MINUTES .................................................... 10
Contains Nonbinding Recommendations 

Guidance for Industry1

Formal Meetings Between the FDA and 

Sponsors or Applicants 

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It 

does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 

You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 

and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 

implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate 

number listed on the title page of this guidance. 

I. INTRODUCTION 

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

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

of drug or biological drug products (hereafter products) regulated by the Center for Drug 

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

(CBER). This guidance does not apply to abbreviated new drug applications. For the purposes 

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

following the request procedures provided in this guidance and includes meetings conducted in 

any format (i.e., face to face, teleconference, or videoconference). 

This guidance discusses the principles of good meeting management practices (GMMPs) and 

describes standardized procedures for requesting, preparing, scheduling, conducting, and 

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

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

This guidance supersedes the guidance for industry Formal Meetings With Sponsors and 

Applicants for PDUFA Products published February 2000. The 2000 guidance implemented 

section 119(a) of the Food and Drug Administration Modernization Act of 1997, and reflected a 

unified approach to all formal multidisciplinary meetings between sponsors or applicants and the 

FDA. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable 

responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 

 

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 This guidance has been prepared by the Office of New Drugs Meeting Management Process Improvement Team, 

comprising individuals from the Office of New Drugs, in cooperation with other offices in the Center for Drug 

Evaluation and Research (CDER) and with the Center for Biologics Evaluation and Research at the Food and Drug 

Administration. 

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Contains Nonbinding Recommendations 

be viewed only as recommendations, unless specific regulatory or statutory requirements are 

cited. The use of the word should in Agency guidances means that something is suggested or 

recommended, but not required. 

II. BACKGROUND 

Each year, FDA review staff participate in many meetings with sponsors or applicants who seek 

guidance relating to the development and review of investigational new drugs and biologics, and 

drug or biological product marketing applications. Because these meetings often represent 

critical points in the regulatory process, it is important that there are efficient, consistent 

procedures for the timely and effective conduct of such meetings. The GMMPs in this guidance 

are intended to provide consistent procedures that will promote well-managed meetings, and 

ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and 

documented appropriately. 

III. MEETING TYPES2

There are three types of meetings that occur between sponsors or applicants and FDA staff: Type 

A, Type B, and Type C. Each meeting type is subject to different procedures, as described 

below. 

A. Type A Meeting 

A Type A meeting is a meeting needed to help an otherwise stalled product development 

program proceed. Examples of a Type A meeting include: 

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

the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level3

• Meetings to discuss clinical holds in which a response to hold issues has been submitted, 

but the FDA and the sponsor or applicant agree that the development is stalled and a new 

path forward should be discussed 

• Special protocol assessment meetings that are requested by sponsors or applicants after 

receipt of FDA evaluation of protocols under the special protocol assessment procedures 

as described in the guidance for industry Special Protocol Assessment

 

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 The meeting types and goal dates were negotiated under PDUFA and apply to formal meetings between FDA staff 

and sponsors or applicants of PDUFA products; they do not apply to meetings with CDER Office of Generic Drugs 

(OGD), CDER Office of Compliance, or CDER Division of Drug Marketing, Advertising, and Communications 

(DDMAC). However, OGD will attempt to meet the time frames set out under Type A and Type C meetings, and 

CDER Office of Compliance and DDMAC will apply GMMPs to the extent possible with the exception of the 

specific meeting types and goal dates. 

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 We update guidances periodically. To make sure you have the most recent version of a guidance, check the CDER 

guidance Web page at http://www.fda.gov/cder/guidance/index.htm. 

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Contains Nonbinding Recommendations 

If sponsors or applicants are considering a request for a Type A meeting, before submitting the 

request they should contact the review division in either CBER or CDER to discuss the 

appropriateness of the request. Type A meetings should be scheduled to occur within 30 days of 

FDA receipt of a written meeting request. If a sponsor or applicant requests a meeting date that 

is beyond 30 days from the date of the request receipt, we will work with the sponsor or 

applicant to determine the earliest agreeable date. 

B. Type B Meeting 

Type B meetings are as follows:4

• Pre-investigational new drug application (pre-IND) meetings (21 CFR 312.82) 

• Certain end-of-phase 1 meetings (21 CFR 312.82) 

• End-of-phase 2 and pre-phase 3 meetings (21 CFR 312.47) 

• Pre-new drug application/biologics license application meetings (21 CFR 312.47) 

Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written 

meeting request. If a sponsor or applicant requests a meeting date that is beyond 60 days from 

the date of request receipt, we will work with the sponsor or applicant to determine the earliest 

agreeable date. 

To promote efficient management of formal meetings, the requestor should try to anticipate 

future needs and, to the extent practical, combine product development issues into the fewest 

possible meetings. Generally, we will not grant more than one of each of the Type B meetings 

for each potential application (e.g., investigational new drug application (IND), new drug 

application (NDA), biologics license application (BLA)) or combination of closely related 

products developed by the same sponsor or applicant (e.g., same active ingredient but different 

dosage forms being developed concurrently), but we can do so when it would be beneficial to 

hold separate meetings to discuss unrelated issues. It also may be appropriate to conduct more 

than one of some of the Type B meetings for concurrent development of a product for unrelated 

claims. 

C. Type C Meeting 

A Type C meeting is any meeting other than a Type A or Type B meeting between CBER or 

CDER and a sponsor or applicant regarding the development and review of a product. 

Type C meetings should be scheduled to occur within 75 days of FDA receipt of the written 

meeting request. If a sponsor or applicant requests a meeting date that is beyond 75 days from 

 

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 Type B meetings are not held in OGD. 

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Contains Nonbinding Recommendations 

the date of the request receipt, we will work with the sponsor or applicant to determine the 

earliest agreeable date. 

IV. MEETING REQUESTS BY SPONSORS OR APPLICANTS 

To make the most efficient use of FDA resources, before seeking a meeting with CBER or 

CDER, sponsors or applicants should consider other sources of input applicable to their product 

development program, such as FDA and International Conference on Harmonization (ICH) 

guidances. If a meeting is still needed, written correspondence to request such a meeting should 

be submitted to the sponsor’s or applicant’s application (e.g., IND, NDA, BLA) through the 

controlled document system. If there is no application, the request should be submitted to either 

the appropriate CDER division director with a copy sent to the division’s chief of the project 

management staff or to the appropriate office contact within CBER. Before submitting any 

meeting request by fax or e-mail when there is no application, the sponsor or applicant should 

contact the appropriate review division to determine to whom the request should be directed, 

how the request should be submitted, the appropriate format for the request, and to arrange for 

confirmation of receipt of the request. This prevents the possibility that faxed or e-mailed 

requests will be overlooked because of the volume of e-mails received daily by FDA staff. 

Faxed or e-mailed requests should be sent during official business hours (8:00 a.m. to 4:30 p.m. 

EST/EDT) Monday through Friday (except Federal government holidays). Processing and 

receipt may be delayed for requests where confirmation of receipt has not been pre-arranged. 

The meeting request, regardless of the method of submission, should include adequate 

information for the FDA to assess the potential utility of the meeting and to identify FDA staff 

necessary to discuss proposed agenda items. The meeting request should include the following 

information: 

1. Product name. 

2. Application number (if applicable). 

3. Chemical name and structure. 

4. Proposed indication(s) or context of product development. 

5. Type of meeting being requested (i.e., Type A, Type B, or Type C). If a Type A meeting 

is requested, the rationale should be included. 

6. A brief statement of the purpose and objectives of the meeting. This statement should 

include a brief background of the issues underlying the agenda. It also can include a brief 

summary of completed or planned studies and clinical trials or data that the sponsor or 

applicant intends to discuss at the meeting, the general nature of the critical questions to 

be asked, and where the meeting fits in overall development plans. Although the 

statement should not provide detailed documentation of trial designs or completed studies 

and clinical trials, it should provide enough information to facilitate understanding of the 

issues, such as a small table that summarizes major results. 

7. A proposed agenda. 

8. A list of proposed questions, grouped by discipline. For each question there should be a 

brief explanation of the context and purpose of the question. 

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Contains Nonbinding Recommendations 

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

meeting from the sponsor’s or applicant’s organization and consultants. 

10. A list of FDA staff, if known, or disciplines asked to participate in the requested meeting. 

11. Suggested dates and times (e.g., morning or afternoon) for the meeting that are within or 

beyond the appropriate time frame of the meeting type being requested. 

12. The format of the meeting (i.e., face to face, teleconference, or videoconference). 

The sponsor or applicant, when writing a meeting request that contains the above components 

(items 1-12), should define the specific areas of input needed from CBER or CDER. A wellwritten meeting request that uses the above components as a guide can help the FDA understand 

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

Although CBER or CDER will determine the final meeting type (i.e., Type A, Type B, or Type 

C), the sponsor or applicant should provide its meeting type assessment as it relates to the 

product’s development. The list of sponsor or applicant attendees and the list of requested FDA 

attendees can be useful in providing or preparing for the input needed at the meeting. However, 

during the time between the request and the meeting, the projected attendees can change. 

Therefore, an updated list of attendees with their titles and affiliations should be included in the 

meeting package and a final list provided to the appropriate FDA contact before the meeting (see 

section VII.C.). 

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

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

sponsor or applicant and to focus the discussion, should the meeting be granted. Each question 

should be precise and include a brief explanation of the context and purpose of the question. 

V. ASSESSING MEETING REQUESTS 

The CBER or CDER division director or designee who receives a meeting request will determine 

whether to hold the meeting and will respond to the sponsor or applicant by granting or denying 

the meeting within 14 days of receipt of the request for Type A meetings and within 21 days for 

Type B and Type C meetings. 

A. Meeting Denied 

If a meeting request is denied, notification to the sponsor or applicant will include an explanation 

of the reason for the denial. Denials will be based on a substantive reason, not merely on the 

absence of a minor element of the meeting request or meeting package items. For example, a 

meeting can be denied because it is premature for the stage of product development. A 

subsequent request to schedule the meeting will be considered as a new request (i.e., a request 

that merits a new set of time frames as described in section III). 

B. Meeting Granted 

If a meeting request is granted, CBER or CDER will notify the sponsor or applicant of the 

decision and schedule the meeting by determining the meeting type, date, time, length, place, and 

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Contains Nonbinding Recommendations 

expected FDA participants. All of the scheduling information will be forwarded to the sponsor 

or applicant as soon as possible following the granting notification, and within the specified 

PDUFA timelines. 

VI. RESCHEDULING AND CANCELLING MEETINGS 

Occasionally, circumstances arise that necessitate the rescheduling or cancelling of a meeting. If 

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

date. A new meeting request should not be submitted and new time frames should not be set for 

rescheduled meetings. However, if a meeting is cancelled, we will consider a subsequent request 

to schedule a meeting to be a new request (i.e., a request that merits a new set of time frames as 

described in section III). Sponsors or applicants and the FDA should take reasonable steps 

together to avoid rescheduling and cancelling meetings (unless the meeting is no longer 

necessary). For example, if an attendee becomes unavailable, a substitute can be identified, or 

comments on the topic that the attendee would have addressed can be forwarded to the sponsor 

or applicant following the meeting. It will be at the discretion of the review division whether the 

meeting should be rescheduled or cancelled depending on the specific circumstances. 

The following situations are examples of when a meeting can be rescheduled. This list includes 

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

• The sponsor or applicant experiences a minor delay in submitting the meeting package. 

The sponsor or applicant should contact the CDER regulatory project manager (RPM) or 

appropriate point of contact in CBER to explain why it cannot meet the time frames for 

submission and when the meeting package will be submitted. 

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

information is needed to address the sponsor’s or applicant’s questions or other important 

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

arrange for its submission. 

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

voluminous (see section VII.C.), despite submission within the specified time frames and 

the appropriateness of the content. 

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

emergency. 

• After the meeting package is submitted, the sponsor or applicant sends CBER or CDER 

additional questions or data that are intended for discussion at the meeting and require 

additional review time. 

• It is determined that attendance by additional FDA organizations not originally 

anticipated or requested by the sponsor or applicant, such as the Office of the Chief 

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Contains Nonbinding Recommendations 

Counsel, are critical and their availability precludes holding the meeting on the original 

date. 

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

• The sponsor or applicant determines that premeeting responses to its questions are 

sufficient for its needs and additional discussion is not necessary (see section VIII.). In 

this case, the sponsor or applicant should contact the CDER RPM or appropriate point of 

contact in CBER to request cancellation of the meeting. The division will consider 

whether it agrees that the meeting should be cancelled. Some meetings, particularly 

milestone meetings, can be valuable because of the broad discussion they generate and 

the opportunity for the division to ask about relevant matters (e.g., dose-finding, breadth 

of subject exposure, particular safety concerns), even if the premeeting communications 

seem sufficient to answer the sponsor’s or applicant’s questions. If the division agrees 

that the meeting can be cancelled, the division will document the reason for cancellation 

and the premeeting communication will represent the final responses and the official 

record. 

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

section VII.A.) or is grossly inadequate. Meetings are scheduled on the condition that 

appropriate information to support the discussion will be submitted with sufficient time 

for review and preparatory discussion. Adequate planning should avoid this problem. 

VII. MEETING PACKAGE CONTENT AND SUBMISSION 

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

information. Preparing the meeting package should help the sponsor or applicant focus on 

describing its principal areas of interest. The meeting package should provide information 

relevant to the discussion topics and enable the FDA to prepare adequately for the meeting. In 

addition, the timely submission of the meeting package is important for ensuring that there is 

sufficient time for meeting preparation, accommodating adjustments to the meeting agenda, and 

accommodating appropriate premeeting communications. 

A. Timing of Submission 

A meeting package should be submitted to the appropriate review division so that it is received 

in accordance with the following time frames: 

• Type A meeting — At least 2 weeks before the formal meeting. 

• Type B meeting — At least 4 weeks before the formal meeting. 

• Type C meeting — At least 4 weeks before the formal meeting. 

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Contains Nonbinding Recommendations 

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

Meeting packages should be submitted to the appropriate review division. The meeting package 

should identify the date, time, and subject of the meeting. An archival copy should be submitted 

to the relevant application (e.g., IND, NDA, or BLA); if there is no established application (e.g., 

for a pre-IND meeting), the responsible point of contact in the review division will provide 

instructions on how to submit the meeting packages. We encourage sponsors or applicants to 

submit the archival meeting package electronically according to the electronic submission 

formatting recommendations (see the draft guidance for industry Providing Regulatory 

Submissions in Electronic Format — General Considerations5). 

The number of copies of a meeting package will vary based on the meeting. The responsible 

point of contact in the review division will advise on the number of copies needed for the 

meeting attendees. To facilitate the meeting process, we strongly suggest that copies of meeting 

packages provided in electronic format also be provided in paper. 

C. Meeting Package Content 

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

supplementary information needed to develop responses to issues raised by the sponsor or 

applicant or review division. Full study and trial reports or detailed data generally are not 

appropriate for meeting packages; the summarized material should describe the decisions and 

results of relevant studies and clinical trials with some degree of quantification. The trial 

endpoints should be stated, as should whether endpoints were altered or analyses changed. Also, 

merely describing a result as significant does not provide the division with enough information to 

give good advice or identify important problems the sponsor or applicant may have missed. It is 

critical that the meeting package content support the intended meeting objectives. The meeting 

package content will vary depending on the product, indication, phase of product development, 

and issues to be discussed. FDA and ICH guidances identify and address many issues related to 

product development and should be considered in planning, developing, and providing 

information needed to support a meeting with the FDA. If a product development plan deviates 

from current guidances, or from current practices, the deviation should be recognized and 

explained. Known difficult design and evidence issues should be raised for discussion (e.g., use 

of a surrogate endpoint, reliance on a single study use of a noninferiority design, adaptive 

designs). 

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

proposed agenda. The meeting package should be a sequentially paginated document (individual 

sections can be numbered separately, as long as there is an overall pagination covering the whole 

submission) with a table of contents, appropriate indices, appendices, cross references, and tabs 

differentiating sections. Meeting packages generally should include the following information: 

1. Product name and application number (if applicable). 

2. Chemical name and structure. 

 

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 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a 

guidance, check the CDER guidance Web page at http://www.fda.gov/cder/guidance/index.htm. 

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Contains Nonbinding Recommendations 

3. Proposed indication. 

4. Dosage form, route of administration, and dosing regimen (frequency and duration). 

5. An updated list of sponsor or applicant attendees, affiliations, and titles. 

6. A background section that includes the following: 

a. A brief history of the development program and the events leading up to the meeting. 

b. The status of product development (e.g., the target indication for use). 

7. A brief statement summarizing the purpose of the meeting. 

8. A proposed agenda. 

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

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

10. Data to support discussion organized by discipline and question. For example, for an 

end-of-phase 2 meeting, this section should include the following, if not already provided 

in the background section (refer to item #6 above): description and results of controlled 

trials conducted to determine dose-response information; adequately detailed descriptors 

of planned phase 3 trials identifying major trial features such as trial population, critical 

exclusions, trial design (e.g., randomization, blinding, choice of control group, with 

explanation of the basis for any noninferiority margin if a noninferiority trial is used), 

choice of dose, primary and secondary trial endpoints; and major analyses (including 

planned interim analyses and adaptive features, and major safety concerns). 

VIII. PREMEETINGS AND COMMUNICATIONS WITH SPONSORS OR 

APPLICANTS 

CBER and CDER hold internal meetings to discuss meeting packages and to gain internal 

agreement on the preliminary responses to a sponsor’s or applicant’s questions. We may 

communicate these preliminary responses to the sponsor or applicant. Communications before 

the meeting between sponsors or applicants and the FDA, including preliminary responses, can 

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

premeeting communications should not be construed as final unless there is agreement between 

sponsor or applicant and the FDA that additional discussion is not necessary. Preliminary 

responses communicated by the FDA are not intended to generate the submission of a new 

meeting agenda and new questions. If, however, a sponsor or applicant provides new data or a 

revised or new proposal, the FDA may not be able to provide comments on the new data or it 

may generate the need for the submission of a new meeting request by the sponsor or applicant. 

IX. PROCEDURES FOR THE CONDUCT OF MEETINGS 

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

statement of the agenda. Presentations by sponsors or applicants generally are not needed 

because the information necessary for review and discussion should be part of the meeting 

package. If a sponsor or applicant plans to make a presentation, the presentation should be 

discussed ahead of time with the CBER or CDER point of contact to determine if a presentation 

is warranted and ensure that CBER or CDER has the presentation materials ahead of the meeting 

if possible. All presentations should be kept brief to maximize the time available for discussion. 

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The length of the meeting will not be increased to accommodate a presentation. If a presentation 

contains more than a small amount of new data that are distinct from clarifications or 

explanations of previous data and that were not included in the original meeting package 

submitted to CBER or CDER for review, FDA staff may not be able to provide comments on the 

new data. 

Before the end of the meeting, FDA attendees and the sponsor or applicant attendees should 

summarize the important discussion points, agreements, clarifications, and action items. 

Generally, the sponsor or applicant will be asked to present the summary to ensure that there is 

mutual understanding of meeting outcomes and actions. FDA staff can add or further clarify any 

important points not covered in the summary and these items can be added to the meeting 

minutes. The summary can be done at the end of the meeting or after the discussion of each 

question. 

X. DOCUMENTATION OF MEETINGS 

Documentation of meeting outcomes, agreements, disagreements, and action items is critical to 

ensuring that this information is preserved for meeting attendees and future reference. FDA 

minutes are the official record of the meeting. The official, finalized minutes will be issued to all 

FDA attendees (with copies to appropriate files) and to the sponsor or applicant within 30 days 

of the meeting. 

XI. RESOLUTION OF DISPUTE ABOUT MINUTES 

This section refers to disputes about the accuracy and sufficiency of the minutes, not to whether 

the positions taken by the FDA are the correct ones. The latter is subject to the standard appeal 

procedures (21 CFR 10.75; 21 CFR 312.48 and 314.103). 

A sponsor or applicant who needs additional clarification of the meeting minutes issued by the 

FDA should contact the assigned FDA point of contact for guidance. This process addresses 

issues with the meeting minutes only. If a sponsor or applicant needs to discuss additional issues 

that were not addressed at the meeting, it should submit a correspondence or a new meeting 

request. 

If, after following up as described above, there are still significant differences in understanding 

regarding the content of the official meeting minutes, the sponsor or applicant should notify the 

FDA in writing of specific disagreements. The sponsor or applicant should submit the 

correspondence to its application or, if there is no application, forward a letter to the division 

director of the responsible division, with a copy to the point of contact describing the concern. 

The sponsor’s or applicant’s concerns will be taken under consideration by the review division 

and the office director if the office director was present at the meeting. If the minutes are 

deemed to accurately reflect the meeting discussion, the point of contact will convey this 

decision to the sponsor or applicant and the minutes will stand as the official documentation of 

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11 

the meeting. If after discussions with the sponsor or applicant the FDA deems it necessary to 

effect a change to the official minutes, the changes will be documented in an addendum to the 

official minutes. The addendum will also document any continued sponsor or applicant 

objections.