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Guidance on Pharmaceutical Carcinogenicity Testing

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Federal Register notice: FDA makes available a final guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Phar...

Oncology Drug Cross Labeling Guidance

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FDA publishes a guidance on cross-labeling of oncology drugs used in combination regimens.

Teleflex Filter Recall is Class 1

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FDA says the Teleflex recall of 60,000 Iso-Gard Filter S units is Class 1.

Temporary Clozapine REMS Enforcement Discretion

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FDA announces new enforcement discretion and reiterates previous enforcement discretion relating to issues with the clozapine REMS...

Guide on Expanded Access for Investigational Drugs

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Federal Register notice: FDA makes available a revised draft guidance entitled Expanded Access to Investigational Drugs for Treatm...

Guilty Pleas in Drug Kickback Conspiracy

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The Justice Department says an Ohio doctor and an Avanir Pharmaceuticals employee have pleaded guilty to their roles in a drug kic...

New Requests in Radius Petition Supplement

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Radius Health files a supplement to its earlier Tymlos petition with three additional actions it wants FDA to take.

Petition Seeks Reclassification of BD Mesh/Scaffolds

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Cardiac surgeon Hooman Noorchashm petitions the agency asking it to change the classification of Becton Dickinsons poly 4-hydroxyb...

Lawmakers Question FDA on Canadian Drug Importation

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Six Republican lawmakers urge FDA commissioner Robert Califf to update them about an ongoing delay to review Floridas proposed Can...

Amazon Distributing Misbranded, Unapproved Drugs: FDA

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FDA warns Amazon.com it is distributing unapproved new drugs.