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Vaccines, Blood & Biologics
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Resources for You
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Regulatory Submissions in Electronic Format for Biologic Products
There are extensive requirements in the Code of Federal Regulations (CFR) regarding the information that needs to be submitted in order to seek approval to begin clinical testing of a biologic product and to market a biologic product. FDA has started the transition to a more automated electronic review process for these submissions.
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Key Resources
- Electronic Submissions Gateway
Information on how to submit documents to FDA electonically.
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Information on Electronic Submission of Regulatory Documents to CBER
- Food and Drug Administration Electronic Submissions Gateway (Federal Register Notice) - 8/9/2006
August 9, 2006 - FDA Announces the Use of New Electronic Drug Labels to Help Better Inform the Public and Improve Patient Safety
November 2, 2005 - Individual Case Safety Reports (ICSR) - Specifications
- SOPP 8110: Submission of Regulatory Documents to CBER
Effective Date: February 6, 2003 - SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff
Effective Date: July 15, 2009 - SOPP 8117: Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission
Effective Date: September 24, 2007
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Guidances & Rules
- Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements, Proposed Rule (Federal Register
8/21/2009 - Medical Device Reporting: Electronic Submission Requirements, Proposed Rule (Federal Register)
8/21/2009 - Providing Regulatory Submissions in Electronic Format – (PDF - 123KB)
Drug Establishment Registration and Drug Listing, May 2009 - Indexing Structured Product Labeling (PDF - 59KB)
June 12, 2008 - Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports (PDF - 107KB)
June 11, 2008 - Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 133KB)
June 11, 2008
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Contact Us
- (800) 835-4709
- (301) 827-1800
- matt@fda.hhs.gov
Manufacturers Assistance and Technical Training Branch (CBER)
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-41
Rockville, MD 20852-1448
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