FDA sends Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspected 10/2023.
Federal Register notice: FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.
A new HHS white paper on drug shortage policies cites many steps FDA has taken and wants to take in the future.
FDA approves Abbotts TriClip, a transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation.
The FDA Medical Device Development Tool program qualifies the University of California San Francisco Lethal Arrhythmia Database.
FDA approves Basilea Pharmaceuticas antibiotic Zevtera for three indications.
Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for treating presbyopia, whi...
FDA grants Prenosis a de novo marketing authorization for its Sepsis ImmunoScore, an artificial intelligence/machine learning software for guiding rap...
