Articles by James A. Taylor, PhD - BioPharm International

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Articles by James A. Taylor, PhD

James A. Taylor, PhD


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