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

Description

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 referred to as 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, applications for biosimilar biological products, or submissions for medical devices.  For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester(s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., in person face-to-face, virtual face-to-face (video conference), teleconference, and written response only (WRO) see in section IV, Meeting Formats).

Scope & Applicability

Regulatory Context

• 21CFR10.75§ 10.75 Internal agency review of decisions.

  (a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →

• 21CFR312.48§ 312.48 Dispute resolution.

  (a) General. The Food and Drug Administration is committed to resolving differences between sponsors and FDA reviewing divisions with respect to requirements for IND's as quickly and amicably as possible through the cooperative exchange of information and views.Read full regulation →

• 21CFR314.103§ 314.103 Dispute resolution.

  (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated applications as quickly and amicably as possible through the cooperative exchange of information and views.Read full regulation →

• 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.

  (a) Filing an NDA.Read full regulation →

• 21CFR312.47§ 312.47 Meetings.

  (a) General. Meetings between a sponsor and the agency are frequently useful in resolving questions and issues raised during the course of a clinical investigation. FDA encourages such meetings to the extent that they aid in the evaluation of the drug and in the solution of scientific problems conceRead full regulation →

• Best Practices for Communication Between IND Sponsors and FDA During Drug Development (Status: Final)
• Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Status: Final)
• Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
• How to Write a Request for Designation (RFD): Guidance for Industry (Status: Final)
• Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (Status: Final)
• CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (Status: Final)
• Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry (Status: Final)