The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among public health experts and the biotech industry.
Biologics
FDA Cites GSK Hungary Vaccine Plant
FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, including failures to assess worst-case conditions for batches later used in the production of widely used vaccines.
