Articles by James A. Taylor, PhD - BioPharm International

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Articles by James A. Taylor, PhD

Final Word: Think Safety and Use Common Sense to Meet New IND GMP Regulations

FDA has eased GMP regulations to help small manufacturers with limited personnel and facilities
Apr 1, 2006

On January 17, 2006, the FDA released new regulations, effective June 1, 2006, which affect the production of most investigational drug and biologic products intended for phase 1 clinical trials. These regulations are much broader in scope than the Exploratory IND guidance released on the same day, and which apply only to low-risk, CDER-regulated clinical studies.

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