Contains Nonbinding Recommendations
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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formatting recommendations (see the draft guidance for industry Providing Regulatory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 Considerations
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).
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.