Biologics Regulations and Guidance
Last Modified: April 05, 2024
Regulations and Regulatory Guidance
- Virus-Serum-Toxin Act of 1913, as Amended 1985
- Code of Federal Regulations (9 CFR)
- Veterinary Services Memoranda
- Center for Veterinary Biologics Public Notices
- Single Tier Label Claim Industry Guidance
- Risk Analysis/Summary Information Formats
Testing
- Supplemental Assay Methods
- Protocols and Standard Operating Procedures (SOPs)
- Reagent Data Sheets
- Center for Veterinary Biologics Reagent Catalog
Other Guidance and Instructional Materials
- NCAH Portal Guidance for CVB Submitters
- Submission Compliance Guide: Submitting Complete and Accurate License Applications, Outlines, and Labels
*For Paper Submissions Only* (March 8, 2021) - Root Cause Analysis Podcast - Transcript
- Polymerase Chain Reaction (PCR) Seminar Series
- Principles and Practices of Good Manufacturing as Required by the Virus-Serum-Toxin Act
- CVB Data Guide (how to submit data to PEL)
CVB Procedure Manuals
- Inspection and Compliance Manual
- Policy, Evaluation, and Licensing (Reviewer) Manual
- Operations Manual
- Decision Tracker Guidance