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CDER has opened the grant submission process for awarding $700,000 to independent organizations that propose holding meetings among a broad range of stakeholders to explore development and implementation of medical policy. Read More
A federal judge has dismissed Eli Lilly’s case against a Florida-based online compounding pharmacy selling copycat Mounjaro (tirzepatide), ruling that only the U.S. government has enforcement authority of the Food, Drug, and Cosmetic Act (FD&C Act), Lilly cannot use state laws for private enforcement. Read More
The FDA is hamstrung from truly mitigating impending drug supply shortages because the agency can’t get a consistently transparent view into drug manufacturers’ operations, FDA Commissioner Robert Califf told the House Committee on Oversight and Accountability during a nearly five-hour hearing on Thursday. Read More
The number of ongoing and active U.S. drug shortages peaked at 323 during the fourth quarter of 2023 — and 48 new medicines have been added to the list so far this year — with last year’s figure marking the highest number since the University of Utah Drug Information Service started tracking this data in 2001. Read More
Members of Parliament adopted their proposals to revamp EU pharmaceutical legislation aimed at fostering innovation and enhancing the security of supply, accessibility and affordability of medicines. Read More
The Department of Justice (DOJ) filed a complaint under the False Claims Act (FCA) against Regeneron Pharmaceuticals alleging that the company knowingly submitted average sales price (ASP) reports to CMS that resulted in inflated Medicare reimbursements to the company. Read More
A new chapter emerged this week in the contentious issue of patent thickets, a web of overlapping patents filed on a single existing product to create barriers to competition and extend effective patent life. Read More
In its first annual report, the CDER Office of Communications pointed to its three main goals, all of which focus on supporting the public’s faith in the FDA to protect public health. Read More
Many drug developers could improve the alignment of their quality units and their business units — and potentially avoid Form 483 inspection observations — if they dusted off and applied the International Council on Harmonization’s ICH Q10 Pharmaceutical Quality System guidance, according to one pharma quality expert. Read More