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FDA sends Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspec...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalen...[ Price : $8.95]
A new HHS white paper on drug shortage policies cites many steps FDA has taken and wants to take in the future.[ Price : $8.95]
FDA approves Abbotts TriClip, a transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation.[ Price : $8.95]
The FDA Medical Device Development Tool program qualifies the University of California San Francisco Lethal Arrhythmia Database.[ Price : $8.95]
FDA approves Basilea Pharmaceuticas antibiotic Zevtera for three indications.[ Price : $8.95]
Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for trea...[ Price : $8.95]
FDA grants Prenosis a de novo marketing authorization for its Sepsis ImmunoScore, an artificial intelligence/machine learning soft...