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.

US Regulatory Guidance Documents & Links