The Abbott/Thoratec recall of HeartMate II and HeartMate 3 left ventricular assist system (LVAS) has been deemed Class I, the most serious type of recall, by the FDA. Source: Drug…

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…

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. Source: Drug Industry Daily

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…

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…

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…

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,…

Less than a month after issuing warning letters to a China-based manufacturer of plastic syringes for various quality and branding violations, the FDA is suggesting U.S. providers and consumers avoid…

Over the past week, the FDA published a request for comments on a meeting to discuss user fee financial transparency and efficiency. Source: Drug Industry Daily

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…