CDRH plans to reclassify most in vitro diagnostic tests (IVD) from class III (high risk) to class II (moderate risk), enabling manufacturers to seek marketing clearance through the premarket notification…

A new non-opioid pain killer holds promise in phase 3 trials, a gene therapy restores hearing lose, a GI cancer trial succeeds, and mushrooms may hold promise in treating pancreatic…

Lapses in digital security, missed report deadlines, and a complete lack of quality oversight earned manufacturers some notable 483s. And here’s a first: How about getting written up for being…

The FDA has issued a revised version of its Biosimilar User Fee Amendment (BsUFA) Research Roadmap and a list of guidances CBER plans to issue during 2024, both intended to…

Establishing the magnitude of the Philips Respironics recall, the FDA has announced that since April 2021, the agency has received more than 116,000 medical device reports (MDR), including 561 reports…

The FDA will have to exponentially ramp up its hiring to properly understand and regulate quickly developing AI and the many ways it’s poised to change development of drugs and…

The FDA has released its long-awaited Quality Management System Regulation (QMSR) final rule, including a change that requires medical device manufacturers to be compliant within two years instead of the…

Biogen is officially pulling the plug on Aduhelm, the controversial antiamyloid antibody that dragged the company through a Congressional investigation, spurred the resignation of a top FDA official, and crashed…

AdvaMed has urged Congress to pass the Tax Relief for American Families and Workers Act of 2024 (H.R.7024) that contains a tax change that would allow businesses to deduct their…

Thirty-five amicus briefs on the issue of the FDA’s approval of the abortion drug mifepristone landed in the Supreme Court of U.S. on Tuesday, all in support of the FDA’s…