The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, ...
Groups representing drugmakers and combination product manufacturers have asked the US Food and Drug Administration (FDA) for more clarity on its recently published draft guidance on the use of ...
The U.S. Food and Drug Administration issued a final rule Friday that codified the agency's position prohibiting certain types of drug master files from being used for biologics license applications ...
WILMINGTON, Del.--(BUSINESS WIRE)--Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today ...
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