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The legal fight around the Inflation Reduction Act’s (IRA) drug price negotiation policy continues as the AARP and Public Citizen have submitted amicus briefs supporting the law and Boehringer Ingelheim filed a lawsuit, joining other drugmakers’ and the U.S. Chamber of Commerce’s challenges. Read More
The Department of Justice (DOJ) has resolved criminal antitrust charges against Teva Pharmaceuticals and Glenmark Pharmaceuticals for price fixing with deferred prosecution agreements, hefty fines, admission that the DOJ’s facts are true and a requirement to divest key lines of business. Read More
The FDA has issued multiple draft and revised product-specific guidances that provide recommendations on the design of bioequivalence studies to support ANDAs and facilitate generic drug product availability. 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
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
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