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Federal Register notice: FDA makes available a revised draft guidance entitled Expanded Access to Investigational Drugs for Treatment Use: Questions a...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.
Cardiac surgeon Hooman Noorchashm petitions the agency asking it to change the classification of Becton Dickinsons poly 4-hydroxybutyrate (P4HB)-based...
