FDA warns West Coast Nuclear Pharmacy about drug compounding violations and drugs produced or held in insanitary conditions.
FDA publishes questions and answers on developing and using transport media during the Covid-19 pandemic.
Fujirebio Diagnostics files a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in assessing Alzheimers dis...
FDA posts a transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act program that outlined agency-sought increased...
FDA says it is accepting proposals to assess the impact of extended-infusion beta-lactam antibacterial drugs on the development of beta-lactam resista...
FDA grants AlloMek Therapeutics an orphan-drug designation for its macrocyclic MEK kinase inhibitor, CIP-137401, for treating neurofibromatosis Type 1...
FDA grants Mesoblast Ltd. a Fast Track designation for remestemcel-L for treating acute respiratory distress syndrome due to Covid-19 infection.
The Association for Accessible Medicines asks FDA to clarify several issues from a draft guidance on instances when a generic drug company fails to re...