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        Development & Approval Process (CBER)

Formal Meetings for CBER-Regulated Products Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Formal Meetings for CBER-Regulated ProductsDevelopment & Approval Process (CBER) Formal Meetings for CBER-Regulated Products
  	
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    PrintMeetings with industry and sponsor-investigators are a forum for the Agency to provide guidance to representatives of the regulated industry and/or individual sponsor-investigators during product development and facility design, and to facilitate their compliance with the regulations governing development and post-approval marketing of products.

Formal meetings can be conducted face-to-face, in-person and/or virtually, or via teleconference. Written Response Only (WRO) can be sent in lieu of holding a meeting. CBER will make every effort to grant the requested format. CBER may determine a WRO to be appropriate for some meetings based on several factors. **Please see SOPP 8101.1 - Appendix D: Considerations for Meetings versus Written Responses Only (WRO) for PDUFA Meetings for more information on considerations for converting meeting requests to a WRO**. Please see Update on In-Person Face-to-Face Formal Meetings with FDA for the latest on the return to face-to-face in-person meetings at FDA. The conduct of the meetings and any additional information can be found in the following documents below:

Draft Guidance for Industry: *Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products*, CDER/CBER
	Draft Guidance for Industry: *Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products*, CDER/CBER
	SOPP 8101.1: *Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products*(Please note that INTERACT was formalized under PDUFA VII and these meetings are now subject to performance goals.)

Requestors are encouraged to send meeting requests electronically via the FDA Electronic Submissions Gateway (ESG) to CBER.  Requests not required to be submitted in the eCTD format via the Electronic Submissions Gateway can be emailed as a PDF submission to CBERDCC_eMailSub@fda.hhs.gov. Electronic or email submission is preferred, but requestors may submit paper or electronic media (USB drive, CD, DVD) documents and other regulatory correspondence to the Document Control Center at CBER mailing address:

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

                                                                                  Content current as of:
      01/26/2024Formal Meetings for CBER-Regulated Products
 
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