By overriding the FDA’s scientific judgments and methodology, the Fifth Circuit second-guessed the FDA’s Congressional mandate to consider all scientific evidence in drug approval decisions, the American Bar Association (ABA)…
A bipartisan group of six senators have released proposed reforms to the beleaguered 340B drug discount program that they claim will ensure the program fulfills its original purpose of supporting…
Evaluating the accuracy of pulse oximeter readings on individuals with differing skin pigmentation, and differentiating between the device’s medical vs. OTC versions dominated the discussions during Friday’s FDA advisory committee…
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations…
Novo Nordisk has agreed to acquire three fill-finish sites in connection with a transaction where Novo Holdings has agreed to acquire Catalent, a contract development and manufacturing company headquartered in…
The Biden administration has sent initial offers to manufacturers of the first 10 drugs selected for drug price negotiation, saying this is the first time Medicare is not accepting the…
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…
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…
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…