Vaccines, Blood & Biologics
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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 electronically.
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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, 2006FDA Announces the Use of New Electronic Drug Labels to Help Better Inform the Public and Improve Patient Safety
November 2, 2005Individual Case Safety Reports (ICSR) - Specifications SOPP 8110: Submission of Paper Regulatory Applications to CBER Effective Date: June 3, 2010 SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff Effective Date: April 23, 2012 SOPP 8117: Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission Effective Date: September 24, 2007 Submission of Data in CDISC Format to CBER Effective Date: May 15, 2010 Updated: January 3, 2010
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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 – Drug Establishment Registration and Drug Listing (PDF - 123KB)
Drug Establishment Registration and Drug Listing, May 2009Indexing Structured Product Labeling (PDF - 59KB)
June 12, 2008Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports (PDF - 107KB)
June 11, 2008Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 133KB)
June 11, 2008Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications (PDF - 582KB)
November 1999
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Contact FDA
(800) 835-4709
(301) 827-1800
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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