OAP Acting Director
FDA's Edward Cox accepts position as director for the Office of Antimicrobial Products after serving as acting director since August of 2006. Cox joined the Division of Special Pathogen and Immunologic Drug Products in 1998 and has served as acting director for the Office of Drug Evaluation IV...
You may also be interested in...
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”