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Krystal Biotech is offloading its priority review voucher (PRV) for a cool $100 million to an undisclosed buyer, a practice that nets companies cash — in highly variable amounts. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
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. Read More
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 — to gradually turn to bone. Read More
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 Freedom of Information Act (FOIA) request for documents on reasons the FDA hasn’t yet made a decision. Read More
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on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating bioequivalence for type A medicated articles containing certain active pharmaceutical ingredient(s). Read More
The FDA requested that AstraZeneca devise a comprehensive plan of action to “disseminate truthful, non-misleading and complete” corrective communication. Read More
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 urinary tract symptoms caused by benign prostatic hyperplasia. Read More
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. Read More
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 FDA loosened prescribing requirements in 2016. Read More
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 audit to check that regulatory box or if you’re not properly analyzing the data that comes out of those audits, you’re missing a real opportunity, says quality expert says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More