Vaccines, Blood & Biologics
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Dear Health Care Provider Letters:Improving Communication of Important Safety Information(PDF - 128KB)
CDER/CBER, January 2014
- Draft Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics (PDF - 252KB)
CDER/CBER, June 2013
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
CDER/CBER,April 2013 (This document supersedes “User Fees and Refunds for Premarket Approval Applications” dated November 24, 2003.)
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)
CDRH/CBER, April 2013 (This document supersedes “User Fees and Refunds for Premarket Notification Submissions (510(k)s)” issued August 27, 2009)
- Revised Draft Guidance: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 287KB)
CDER/CBER, March 2011 (This guidance is a revision of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions in User Fees (1993 interim guidance), issued July 16, 1993).
- Draft Guidance for Industry and Investigators; Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 227KB)
CDER/CBER, September 2010
- Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (PDF - 316KB)
CDER/CBER/CDRH, September 2009
Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria
CDRH/CBER, August 2009 (This document supersedes “Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria,” issued on October 4, 2004. )
- Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants_PRA (PDF - 95KB)
CDER/CBER, May 2009 (This guidance supersedes the guidance for industry Formal Meetings With Sponsors and Applicants for PDUFA Products published February 2000.)