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FDA Proposes Revised Rules on Experimental Drugs

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FDA says proposed rules on access to and charging for experimental drugs used in treatment should eliminate confusion that has exi...

FDA Class 1 Recall on Glucose Test Strips

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FDA classifies as Class 1 two earlier recalls involving counterfeit blood glucose test strips used in LifeScans One Touch monitor....

FDA Clears OTC Light Hair Removal System

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FDA clears a Palomar Medical Technologies 510(k) for an over-the-counter light-based hair removal device.

FDA Action on Accomplia Set for April

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FDA sets a user fee action date of 4/26/07 for Sanofi-Aventis NDA resubmission on weight-loss drug Acomplia.

FDA, Baxter Warning on Heparin Thrombotic Events

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FDA and Baxter warn healthcare professionals about the possibility of delayed onset of heparin-induced thrombocytopenia.

FDA OKs IVX Animal sANADA

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Federal Register Final rule: FDA approves an IVX Animal Health supplemental ANADA to revise labeling of generic oxytetracycline to...

Gilead Will Comply with Subpoena, Probe

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The U.S. Attorney in San Francisco subpoenas marketing and medical education documents from Gilead Sciences for three HIV drugs.

Grassley Vows to Keep Fighting FDA Secrecy

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As incoming House Government Reform chairman Henry Waxman takes note, Sen. Chuck Grassley lambastes FDA secrecy and alleged intimi...

FDA OKs Velcades Use in MCL

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FDA approves a Millennium Pharmaceuticals supplemental NDA for Velcades use in treating relapsed mantle cell lymphoma.

FDA Approves Agri Labs ANADA for Airsacculitis

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Federal Register Final rule: FDA approves an Agri Laboratories ANADA that provides for oral use of lyncomycin and spectinomycin to...