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FDA Approves GE Healthcares Vizamyl

[ Price : $8.95]

FDA approves GE Healthcares Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission to...

FDA Backs Stricter Controls for Hydrocodone Combination Products

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FDA decides to recommend that hydrocodone combination products, such as Vicodin, be reclassified from Schedule III to Schedule II.

FDA Seeks Help in Tobacco Committee Selection

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Federal Register Notice: FDA seeks participants interested in helping to select nonvoting industry representatives on the Tobacco ...

FDA Approves Abbotts MitraClip

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FDA approves Abbotts catheter-based MitraClip therapy for treating patients suffering from mitral regurgitation.

Under Fire, FDA Panel Chair Withdraws Industry Presentation

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Responding to criticism, FDA Dermatologic and Ophthalmic Drugs Advisory Committee chair Lynn Drake withdraws her acceptance of an ...

FDA Approves Zogenix Opioid Pain Drug

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FDA has approved a Zogenix NDA for Zohydro ER (hydrocodone bitartrate extended-release capsules) for managing severe pain.

Increased Nanotechnology Regulatory Science Research Needed: CDER

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The CDER Nanotechnology Risk Assessment Working Group says increased nanotechnology regulatory science research and up-to-date tra...

FDA Breakthrough Status for Alexion Metabolic Disorder Drug

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FDA grants Alexion Pharma International a Breakthrough Therapy designation for its cyclic pyranopterin monophosphate, an enzyme co...

Researchers Suggest Models for Expanded Trial Data Sharing

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Researchers suggest four models that could accommodate increased calls for greater sharing of clinical trial data.

Draeger Anesthesia Machine Recall is Class 1

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FDA says a Draeger recall of Medical Fabius series anesthesia machines is Class 1.