Frederick Ball

Frederick Ball

Duane Morris LLP

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FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs. Specifically, the Guidance...more

6/19/2013 - CGMP Drug Manufacturers FDA FDCA Prescription Drugs Required Documentation

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