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What is the FDA’s policy regarding charging for investigational drugs and biologics?
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About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

On August 13, 2009, FDA issued 21 CFR Part 312 and 316 Charging for Investigational Drugs Under an Investigational New Drug Application; Expanded Access to Investigational Drugs for Treatment Use; Final Rules. These rules address clinical studies conducted under an IND as well as treatment protocols and treatment INDs. Part 312 discusses regular INDs while Part 316 discusses the regulations surrounding orphan drug applications.

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