Kopcha Named Director of FDA Quality Office
October 02, 2015.
Industry veteran Michael Kopcha, a pharma was named the permanent director of FDA’s Office of Pharmaceutical Quality (OPQ) last week. He will join the Center for Drug Evaluation and Research (CDER) in November pending ethics clearance.
FDA’s OPQ was launched in January 2015 to implement processes and policies to provide better alignment among review, inspection, and research functions.
Kopcha will lead OPQ in planning and implementing strategies to drive pharmaceutical quality, with a goal of providing for an efficient pharmaceutical manufacturing sector that reliably produces high-quality medicines without extensive regulatory oversight, an FDA press release reported.
Is Artificial Intelligence a ‘Product’? Products Liability Implications for AI-Based Products
April 10th 2025As the physical products we use evolve to become increasingly complex, traditional products liability frameworks may not always fit to provide remedies for harm that can result from using novel product types.
