New Guidance: Formal Meetings Between the FDA and Sponsors or Applicants

The new "Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants" 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 regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance supersedes the "Guidance for Industry Formal Meetings With Sponsors and Applicants for PDUFA Products" published in 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. The guidance does not apply to abbreviated new drug applications.

Because these meetings often represent critical points in the regulatory process, it is important that there are efficient and consistent procedures for the timely and effective conduct of such meetings. The general principle underlying the conduct of such meetings is that there should be free, full, and open communication about any scientific or medical question that may arise during the clinical investigation.

There are three types of meetings (A, B and C) that occur between sponsors or applicants and FDA. Each meeting type is subject to different procedures, which are described in the Guidance:

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 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.

FDA encourages such meetings to the extent that they aid in the evaluation of the drug and in the solution of scientific problems concerning the drug, to the extent that FDA's resources permit.

What does FDA expect?

  • One contact person in the company  (before/after the meeting)
  • All important and relevant information to be received within the meeting package
  • Schedule should be kept by the company
  • Clear communication strategy

More details can be found in the Guidance.

In Europe there are different meetings with various authorities:

  • Scientific Advice Meeting of the EMEA
  • National meetings with the Authorities
  • Pre-submission-meeting of the EMEA (before the submission of the MAA, not scientific, but rather covers procedural aspects)

Details on meetings and costs can be found on the respective homepages.

Compiled by
Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA)

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