FDA says the Teleflex recall of 60,000 Iso-Gard Filter S units is Class 1.
FDA announces new enforcement discretion and reiterates previous enforcement discretion relating to issues with the clozapine REMS program.
Federal Register notice: FDA makes available a revised draft guidance entitled Expanded Access to Investigational Drugs for Treatment Use: Questions a...
The Justice Department says an Ohio doctor and an Avanir Pharmaceuticals employee have pleaded guilty to their roles in a drug kickback scheme.
Radius Health files a supplement to its earlier Tymlos petition with three additional actions it wants FDA to take.
Cardiac surgeon Hooman Noorchashm petitions the agency asking it to change the classification of Becton Dickinsons poly 4-hydroxybutyrate (P4HB)-based...
Six Republican lawmakers urge FDA commissioner Robert Califf to update them about an ongoing delay to review Floridas proposed Canadian Prescription D...
Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program....
