Quality & Compliance: Demystifying CMC Regulatory Strategy for Biologics, Part 1

| 01 September 2011

Owing to the Biologics Price Competition and Innovation Act of 2009 that permits the US Food and Drug Administration (FDA) to pursue an abbreviated market approval pathway for biologics, along with industry projections that biologics may represent one in every four newly commercialized drugs in the future, much attention is focused on this class of pharmaceutical products.

 

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