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) ...
RAPS

New FDA Guidance Explains Process Behind Safety Labeling Changes for Drugs, Biologics

The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
Hosted on MSN

FDA unveils proposal for streamlined approval of customized drugs for rare diseases

Federal health officials in Washington announced a proposal on Monday aimed at accelerating the development of customized treatments for patients suffering from difficult-to-treat diseases, including ...