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.
Key Resources
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