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Three Eugia Pharma plants in India have received Form 483s following inspections conducted in the last two months, all laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products, among other lapses. Read More
Of the $341 million increase in funding requested for the FDA in President Biden’s FY 2025 budget proposal, $114 million is needed to fund FDA employees’ 5 percent inflation pay increases for both this year and next, according to the agency’s chief financial officer (CFO). Read More
A new CDER sub-center is looking for drug developers with specific in-process studies for a demonstration program intended to boost innovation in clinical trial design. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
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
Holes in the roof, potential mold on and around air vents, and an employee’s garment extensively touching filling apparatus are among the observations listed in the FDA’s Form 483 levied on India-based generic pharma Zydus Lifesciences. 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