GRx+Biosims Presentation Recap: FDA Expectations for Biosimilar Manufacturing Inspections
On day 2 of the AAM GRx+Biosims conference, a learning track regarding FDA Expectations for Biosimilar Manufacturing Inspections was presented by members from both the FDA and private industry. Speakers included: Chris Downey, Ph.D., Division Director, CDER; Shawn Allwein, Ph.D., Vice President Biologics CMC, Teva; and Michael Cutter, Ph.D., Chief Quality Officer, Biocon. Dr. Downey opened […]