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Federal Register notice: FDA makes available a final guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Phar...[ Price : $8.95]
FDA publishes a guidance on cross-labeling of oncology drugs used in combination regimens.[ Price : $8.95]
FDA says the Teleflex recall of 60,000 Iso-Gard Filter S units is Class 1.[ Price : $8.95]
FDA announces new enforcement discretion and reiterates previous enforcement discretion relating to issues with the clozapine REMS...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled Expanded Access to Investigational Drugs for Treatm...[ Price : $8.95]
The Justice Department says an Ohio doctor and an Avanir Pharmaceuticals employee have pleaded guilty to their roles in a drug kic...[ Price : $8.95]
Radius Health files a supplement to its earlier Tymlos petition with three additional actions it wants FDA to take.[ Price : $8.95]
Cardiac surgeon Hooman Noorchashm petitions the agency asking it to change the classification of Becton Dickinsons poly 4-hydroxyb...