What does CFR stand for in regulatory affairs?

CFR stands for Code of Federal Regulations. This is the official compilation of rules and regulations published by the executive departments and agencies of the U.S. federal government. It provides a comprehensive framework for the regulation of various sectors, including drug, medical device, and food safety regulations, which are critical components of regulatory affairs.

The Code of Federal Regulations is divided into 50 titles that represent broad areas subject to federal regulation. For example, Title 21 pertains to Food and Drugs, which is directly relevant to those working in fields such as pharmaceuticals and food safety. Having a clear understanding of the CFR is essential for regulatory professionals, as it governs compliance, enforcement, and policy decisions throughout the industry. Knowing the correct interpretation of CFR is vital for navigating the complexities of U.S. regulatory frameworks.