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on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating…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…
Beyond the regulatory requirement to perform them, regular internal audits can benefit quality, productivity and an organization’s bottom line. But if you’re simply going through the motions of an internal…
Medtronic’s June recall of its Mahurkar Acute Triple Lumen and Mahurkar Acute High Pressure Triple Lumen Catheters, the third recall of the company’s hemodialysis catheters in a year, has been deemed class…