A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II)...

The Trump Administration on Thursday formally invoked the Defense Production Act (DPA) to require 3M to prioritize orders from the Federal Emergency Management Agency for N95 respirator masks and requested that the firm cease exporting respirato...

In just a short time, the COVID-19 pandemic has dramatically changed the way we live and work, strained healthcare systems, and caused companies and governments to prioritize fighting the coronavirus above virtually all else. Regulators have moved...

As COVID-19 continues to spread around the globe, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace.

The European Commission on Friday released a proposal that would defer for a year the Medical Devices Regulation (MDR) from taking effect on 26 May.

A research letter published in JAMA Internal Medicine this week finds that class III medical devices that receive expedited reviews are more likely to be recalled, and after spending less time on the market, than devices that undergo a standard ...