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FDA Approves Additional Vaccine for Upcoming Influenza Season

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FDA says there are now five licensed flu vaccines and 115 estimated doses available after announcing the newest to be approved IB...

FDA Still Going After Unapproved Drugs

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FDA gets a consent decree with Syntho/Intermax Pharmaceuticals, barring the firm from making or distributing unapproved cough-cold...

Nominations Sought for Mammography and Device Panels

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Federal Register Notice: FDA requests nominations for nonvoting industry representatives for its mammography advisory committee an...

Yaz Approved for PMDD Symptoms

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FDA approves Berlex Yaz oral contraceptive for treating PMDD emotional and physical symptoms.

Another Consent Decree $ans Penalty

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Although FDA has fought in court to retain its authority to seek financial remedies (disgorgement of profits and restitution), rec...

Panel Backs Tighter Potency Specs on Levothyroxine

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An FDA joint advisory panel recommends tighter potency specifications for levothyroxine sodium products.

FDA Lacks Nanotechnology Tools: Taylor

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Former FDA deputy commissioner Michael Taylor says FDA should act now to develop its ability to properly regulate nanotechnology.

FDA Adds Blood Container Labels Info to Guidance

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Federal Register Notice: FDA is adding more questions and answers to a guidance on bar code label requirements to include topics o...

Novartis Issues Gleevec Heart Warning

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Novartis says its Gleevec may be associated with increased risk of decreased heart function.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites ALK-Abello, IVF Michigan, Berkline, Medtronic Vascular, and Optimal Wellness Cen...