Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
Executive Summary
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
You may also be interested in...
CBER Will Devote More Time To Non-COVID-19 Work Beginning In Six Months
Center for Biologics and Evaluation and Research is to resume normal operations at the beginning of 2023 and will stop prioritizing resources for COVID-19 regulatory work over non-COVID-19 matters.
User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals
Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.
CMS Needs Regulatory Science, Chief Scientist To Coordinate With US FDA, Former Official Says
Sean Tunis embraces a bigger decision-making role for CMS in product access, while FDA Commissioner nominee Robert Califf also calls for smoother FDA-CMS hand-offs, and CBER Director Peter Marks wants a quicker FDA-CDC approval and deployment process.