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FDA Corrects Rule on BLA Safety Test Requirements

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Federal Register Proposed rule: FDA corrects an incorrect title in an 8/22 Federal Register proposed rule on revocation of general...

Dengue Virus Tests into Class 2

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Federal Register Final order: FDA classifies dengue virus nucleic acid amplification test reagents into Class 2.

FDA OKs New Indication for Xtandi for Prostate Cancer

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FDA approves a new indication for Astellas Pharma and Medivations Xtandi (enzalutamide) capsules to treat patients with metastatic...

Generics Saved U.S. $239 Billion Last Year: GPhA

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A new Generic Pharmaceutical Association report shows that generic drugs saved the U.S. health system $239 billion in 2013, a 14% ...

Group Says Its Uncovered Unreported Drug Adverse Events

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AdverseEvents Inc. says its new drug safety report based on data provided by FDA in response to Freedom of Information Act request...

Digital Coalition Sees Unclear Twitter Guidance Impact

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The Digital Health Coalition says industry practitioners need to work with FDA to find a better way to use Twitter and other commu...

Court Rejects 2nd FDA Diphoterine Classification

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Attorneys Jennifer Thomas and Anne Walsh say a federal judge has twice rejected FDA attempts to classify Prevors Diphoterine Skin ...

Another Off-label Nightmare for FDA: Blog

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The Drug and Device Law blog says an FDA draft guidance on informed consent disclosure of alternative treatments puts drug and med...

OMB OKs Info on Testing Communications on Biologics

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Federal Register Notice: The Office of Management and Budget approves a collection of information on testing communications on bio...

Info on Health & Diet Surveys Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on health and die...