Electronic Reading Room (eFOI)
The CBER Reading Room provides access to documents posted on the CBER website. These documents are ones frequently requested by the public through the Freedom of Information Act.
Final Opinions
Policy Statements
Administrative Staff Manuals
Frequently Requested Records
- Licensed Products
- 510K Devices
- PMAs (Premarket Approval Devices)
- NDA (New Drug Applications)
- Postmarketing Study Commitments
- Transfer of Therapeutic Products to CDER (2003)
Compliance, Surveillance and Enforcement
- Clinical Investigator Inspection List
- Compliance Program Guides for CBER
- NIDPOE (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain) Letters
- Recalls / Withdrawals
- Warning Letters
- Violative Advertising & Promotional Labeling for Approved Biological Products
- Other Compliance Actions
Product Safety & Availability
- Information Sheets
- Letters to Industry / Healthcare Providers / Clinical Investigators
- Safety Information
- Adverse Event Reporting System (AERS) - CDER
- Vaccine Adverse Event Report System (VAERS)
- Shortages
Meetings
Additional Documents Available from FDA
- FDA's Electronic Freedom of Information Reading Room
- Handbook for Requesting Information and Records from FDA
- Compliance Program Guidance Manual - Office of Regulatory Affairs
- Compliance Policy Guides Manual - Office of Regulatory Affairs
- Dockets Management - Official repository for the administrative proceedings and rule-making documents for FDA
- FDA Forms - Biologics - Downloadable forms
- Inspection Guides - Office of Regulatory Affairs