FDA – U.S. Food and Drug Administration
Guidance, Compliance: Regulatory Information (Biologics)
US BIOLOGIC REGULATIONS
The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the Code Of Federal Regulations (CFR). The CFR is divided into 50 titles that represent broad areas subject to Federal regulations. The FDA’s portion of the CFR interprets the Federal Food, Drug and Cosmetic Act and related statutes. Section 21 of the CFR contains most regulations pertaining to food and drugs. The regulations document all actions of all drug sponsors that are required under Federal law.
- Laws, Regulations, and Recommendations Defined
- Biologics Definition
- Biological Regulations Historical Overview
- Historical Dates
- Key Acts and Statutes
- Submission Requirements
US Regulatory Guidance Documents & Links
- IND CMC Requirements
- BLA CMC Submission Requirements
- Sterile Product Submission Requirements
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products - Comparability
FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products - Changes to Biologic
FDA: Changes to An Approved Biologic: Human Blood and Blood Components - FDA: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
