CDER New Molecular Entity (NME) and New Biologic License Application (BLA) Filings and Approvals

 

WHAT: Listing and reviews on New Molecular Entities

WHY: Timely disclosure of drug approval to spur innovation and bring new therapies to market

HOW: Timely posting of FDA review summaries, labeling, press releases 

LEARN

Published by Drug & Device Advisory Group


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