Glossary of Terms

Code of Federal Regulations (CFR)

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

The Code of Federal Regulations contains the current, finalized, and effective rules of the departments and agencies of the US Federal Government, along with any related official interpretations or supplements to those rules. The rules are organized by subject matter into titles, chapters, parts, and sections. Title 21 is the portion that governs food and drugs, and Chapter 1 of Title 21 contains the regulations based on the Federal Food, Drug and Cosmetic Act and governs clinical trials.

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