Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program....
Federal Register notice: FDA makes available a final guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.
FDA publishes a guidance on cross-labeling of oncology drugs used in combination regimens.
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Federal Register notice: FDA makes available a revised draft guidance entitled Expanded Access to Investigational Drugs for Treatment Use: Questions a...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.
