Regulatory Manager: What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products Part 1: Initiating Phase 1 Clinical Trials

Posted 01 August 2009 | By

Biotechnology-derived pharmaceuticals are being developed by many companies whose senior management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products. A 2006 independent study of the US Food and Drug Administration's (FDA) drug approval review process concluded that biotech startups and first-product biotech companies were especially at risk of failing to achieve their goal of market approval:


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