Mindbreeze says it is working with Booz Allen to give CDER regulatory review search capabilities.
FDA grants Arena Pharmaceuticals a fast track designation for APD418, a β3-adrenergic receptor antagonist and cardiac myotrope for treating decom...
FDA denies an Otsuka petition asking that it determine that the companys Samsca was withdrawn for reasons of safety and that no generic forms of the d...
Eye on FDA says the CDER Office of Prescription Drug Promotion issued 10 enforcement letters in 2019 with 21 violations in 11 communications vehicles.
ResMed Corp. (San Diego, CA) agrees to pay more than $37.5 million to resolve alleged False Claims Act violations for paying kickbacks to medical equi...
CDRH director Jeffrey Shuren says customers should follow a Cardinal Health recommendation not to use lots of Level 3 surgical gowns and PreSource pro...
FDA posts information about the 2018 Right to Try law and how certain patients may be able to access unapproved drugs and biologics under it.
FDA approves an ANI Pharmaceuticals ANDA for potassium citrate extended-release tablets USP, 10 mEq and 15 mEq.