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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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