cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process

March 14, 2024 8:45am

Seth A. Mailhot
Husch Blackwell LLP

Joshua M. Oyster
Ropes & Gray LLP

  • Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization
  • Factoring cGMPs into the scope of the FDA’s authority
  • Exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs
  • Conducting laboratory investigations in relation to cGMPs
  • Understanding the influence of cGMPs in products liability litigation
  • Evaluating the costs and impact of enforcement actions