Article Summary:
The FDA has announced the launch of its FDA PreCheck program, which aims to increase regulatory predictability and encourage companies to build drug manufacturing facilities in the US. This initiative is in response to an executive order directing the agency to streamline domestic drug manufacturing reviews and cut unnecessary requirements. The program includes a facility readiness phase with more frequent communication and an application submission phase that streamlines the chemistry, manufacturing, and controls (CMC) process.
The FDA has also appointed a new chief counsel, Sean Keveney, who previously led efforts to withhold government funding from universities accused of discriminating against Jewish students and women. Additionally, the Department of Health and Human Services is ending several mRNA vaccine development projects conducted by the Biomedical Advanced Research and Development Authority (BARDA), citing a lack of effectiveness against upper respiratory infections.
The text also discusses various other FDA actions, including lifting a pause on a Chikungunya vaccine, publishing a report on pharmaceutical quality, granting accelerated approval for a cancer drug, and using nuclear magnetic resonance as a new diagnostic tool. The agency has also resolved a shortage of saline products but has not requested additional funding to accommodate its increasing workload.
Regarding medical devices, the FDA has published information on the use of per- and polyfluoroalkyl substances (PFAS) in medical devices and issued early warnings for two Boston Scientific products related to potential issues with defibrillation leads and Watchman Access Systems.