FDA Regulatory Affairs
FDA Office of Enforcement Acting Director Steven Niedelman will become assistant commissioner for regulatory affairs, a new position, as of Dec. 1. Niedelman has been acting head of enforcement since September, after joining the office as deputy director in July 2001 (1"The Pink Sheet" Sept. 16, p. 23). He previously spent 24 years in the Center for Devices & Radiologic Health's compliance office. Niedelman will continue to report to Associate Commissioner for Regulatory Affairs John Taylor...
You may also be interested in...
The FDA Office of Enforcement's transition to "risk-based" good manufacturing practices oversight will be led by an FDAer with more than two decades of experience in medical device manufacturing regulation
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.