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Allowing courts to overturn science-driven drug approval decisions would open the door to a myriad of partisan legal challenges, exert a chilling effect on the business of drug development, and endanger patients, according to an amicus brief on the Fifth Circuit’s mifepristone restriction decision, filed by seven former FDA commissioners and acting commissioners. Read More
Over the past week, the FDA issued a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation. Final guidances were issued on chimeric antigen receptor T cell (CAR T) products, human gene therapy products and individual patient expanded access applications. Draft guidance was issued on collection of race and ethnicity data in clinical trials. Read More
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 (510(k) pathway than the more stringent premarket approval pathway. Read More
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 cancer in this month’s edition of Research Roundup. Read More
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 too clean? Read More
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 clarify the agency’s priorities for 2024. Read More
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 of deaths, associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the company’s ventilators, BiPAP machines, and CPAP machines. Read More
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 devices, said FDA Commissioner Robert Califf. Read More
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 originally proposed one year. Read More
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 in ignominy. Read More
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 research and development expenses in one year instead of over five years. Read More
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 position, from submitters ranging from single associations to groups with more than 600 members. Read More