cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process
Cathy L. Burgess
Partner, Leader of FDA, Food, Drug & Device Team
Alston & Bird 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
- Unpacking the FDA’s Draft Strategy Document on Innovative Manufacturing Technologies
- Conducting laboratory investigations in relation to cGMPs
- Understanding the influence of cGMPs in products liability litigation
- PFAS and the FDA’s new guidance regarding the testing of ethylene glycol (EG) and diethylene glycol (DEG) in high-risk drug components
- Evaluating the costs and impact of enforcement actions