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

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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

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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

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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

1 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

2 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.

3 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

4 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 well-
written 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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