FDA Approval Process for Medical Devices Course: How to Make the Most of the FDA Pre-submission Process (June 30, 2026 and July 1, 2026)

The course offers key opportunities in understanding U.S. medical device approval pathways, including 510(k), IDE, PMA, and De Novo. It enhances practical skills through interactive case studies and ...
MobiHealthNews

FDA approval process too slow for wireless health

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...
pharmaphorum

FDA accelerated approval path needs improvement, says ICER

That's the conclusion of a just-published report (PDF) from the influential Institute for Clinical and Economic Review (ICER) ...

FDA rejection sparks questions on Replimune drug approval path

Replimune Group Inc. REPL on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for ...