FDA Taps Former Novartis, J&J Employee To Head Pharmaceutical Quality Shop

FDA has tapped former Novartis official Michael Kopcha to head the agency's Office of Pharmaceutical Quality starting in November, with oversight of submission reviews, manufacturing facility assessments and quality surveillance, according to an internal memo sent to FDA staff Friday (Sept. 25). The office was set up in January to create a uniform drug quality program across all domestic and foreign drug manufacturing sites and all drug product areas. Drug center chief Janet Woodcock has headed the pharmaceutical quality shop...