From CGMPs to the Critical Path: FDA Focuses on Innovation, Quality, and Continuous Improvement–Inside and Out

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-07-02-2004, Volume 28, Issue 7

As FDA prepares for the Critical Path initiative, offices across the agency are expanding the use of the risk-based approach to regulation and applying a quality systems approach to internal operations.

Related Content:

Regulatory/GMP ComplianceProcess ValidationManufacturingQuality SystemsPharmaceutical Technology-07-02-2004
Alentis Therapeutics to Advance Anti-Claudin-1 ADCs to Treat Solid Tumors on $181.4 Million Financing
PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy
Frontier Scientific Solutions Plans a Global Free Trade Zone Gateway to Supply Life Sciences Industry on Back of $1.5 Billion Investment