The FDA’s Circulatory System Devices Panel will review premarket applications for two investigational renal denervation devices this week, both designed to help control refractory hypertension by ablating some of the…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily
A federal appeals court has rejected four provisions of an Oklahoma law regulating prescription benefit managers (PBM), arguing the provisions were preempted by existing federal law. Source: Drug Industry Daily
The FDA cites inadequate product labeling as the reason for marking Abiomed’s June recall of its Impella RP Flex with Smart Assist system catheter as class I, the most serious…
After numerous setbacks, Ipsen has won FDA approval for Sohonos (palovarotene), the first treatment for fibrodysplasia ossificans progressiva (FOP), a disease that causes connective tissue — muscle, tendons and ligaments…
Florida has continued its pursuit of a program to import prescription drugs from Canada, this week filing an amended complaint about the FDA’s delay in responding to its July 2022…
Over the past week, the FDA issued final guidance on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating…
A biotech in Friday Harbor, Wash., has been warned by the FDA for failing to report the findings of a phase 2 trial of a combination product for relieving lower…
After nine years in draft form and 127 comments received from stakeholders, the FDA has finalized its guidance on informed consent, adding a question-and-answer section that addresses specific issues. Source:…
A federal appeals court has taken action to allow the abortion medication Mifeprex and its mifepristone generic forms to stay on the market, with the same restrictions that existed before…