Reps. Matsui and Buschon introduce bipartisan legislation they say will help the federal government anticipate and mitigate drug shortages.
Attorney Chia-Feng Lu sees increasing FDA interest in guidance on and enforcement of off-label communications.
The DC federal court approves a six-month stay in FDAs records production for an FOIA request from Childrens Health Defense for records related to Cov...
Three Democrat U.S. Reps. introduce the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is an adequate supply o...
CDER says 45% of drug Warning Letters issued in fiscal year 2023 cited GMP requirement violations.
Federal Register notice: FDA makes available a final guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lin...
FDA grants Darmiyan a de novo marketing authorization for its clinical test BrainSee for assessing Alzheimers dementia risk.
Fresenius Kabi recalls its Ivenix Large Volume Pump because some units have mechanical issues with the fluid valve pins in the devices internal housin...
