ROi CPS recalls its Regard Operative Lap P&S Surgical Kit due to sterility concerns.
FDA grants Hyloris Pharmaceuticals an orphan drug designation for PTX-252 for treating acute myeloid leukemia.
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...
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.
