In regulatory affairs, what does "CFR" stand for?

The term "CFR" stands for "Code of Federal Regulations." This is a key aspect of regulatory affairs as it represents the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the U.S. federal government. The CFR is divided into 50 titles that cover a broad range of topics, including those pertinent to the pharmaceutical, biotech, and medical device industries, which are heavily regulated fields.

The significance of the CFR in regulatory affairs cannot be understated, as it serves as the authoritative source for federal regulations that industry professionals must adhere to. It ensures compliance with established guidelines and standards, thereby protecting public health and safety. Each title in the CFR addresses a specific area of regulation, establishing a framework for how regulations are to be implemented and enforced within the respective domains.

Understanding the meaning and implications of CFR is crucial for anyone involved in regulatory affairs, as it directly influences the processes for product approval, marketing, and surveillance. This knowledge enables professionals to navigate the regulatory landscape effectively and ensure that their organizations remain compliant with federal laws.