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A New Jersey judge ruled last week that Teva Pharmaceuticals did not infringe on two Corcept patents for its Cushing’s syndrome drug Korlym (mifepristone). Read More
The FTC won its motion to temporarily block IQVIA’s planned purchase of California health advertising firm Propel Media, deeming further review by the commission would be in the public interest. Read More
In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers. Read More
The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More
The company was also named in five other warning letters this year aimed at companies selling unapproved and mislabeled drugs via Amazon’s site. Read More
The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT). Read More
Over the past week, the FDA issued a final rule on direct-to-consumer prescription drug advertisements. The agency issued final guidance on development of drugs and biological products for rare diseases, direct-to-consumer promotional labeling and advertisements and, reformulating drug products that contain carbomers manufactured with benzene. Draft guidance was issued on potency assurance for cellular and gene therapy products and quality considerations for topical ophthalmic drugs. Read More
The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal government and stopgap funding is set to expire on Jan. 19 — just over one week after the House and Senate begin the new session. Read More