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.

Key Resources

• Electronic Submissions Gateway

Information on Electronic Submission of Regulatory Documents to CBER

• Food and Drug Administration Electronic Submissions Gateway (Federal Register Notice) - 8/9/2006
• Electronic Submission of Postmarket Safety Reports
• Study Data for Submission to CDER and CBER

Guidances & Rules

• Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review; Guidance for Industry; Technical Specifications Document
• Electronic Submission of Lot Distribution Reports; Guidance for Industry
• Providing Regulatory Submissions in Electronic Format Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
• Providing Submissions in Electronic Format -- Standardized Study Data
• Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions
• Providing Submissions in Electronic Format - Postmarket Non-Expedited ICSRs Technical Questions and Answers
• Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements, Proposed Rule (Federal Register)
• Medical Device Reporting: Electronic Submission Requirements, Proposed Rule (Federal Register)
• Providing Regulatory Submissions in Electronic Format
• Indexing Structured Product Labeling
• Providing Submissions in Electronic Format - Postmarketing Safety Reports for Vaccines
• Providing Regulatory Submissions in Electronic Format--Receipt Date
• Providing Regulatory Submissions in Electronic Format - Content of Labeling
• Providing Regulatory Submissions in Electronic Format - General Considerations
• Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)
• Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications