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FDA Appeals Cigarette Graphic Warnings Injunction

[ Price : $8.95]

FDA files a notice to appeal a federal court order granting a preliminary injunction to delay requirements for cigarette makers to...

Taxotere Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Taxotere injection, 40 mg/mL was not withdrawn from sale for safety or effectiveness ...

FDA Withdraws NDA for Mylotarg

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Federal Register Notice: FDA withdraws approval of a Wyeth NDA for Mylotarg for injection.

FDA OKs Merial NADA for Bovine Parasites

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Federal Register Final rule: FDA approves a Merial Ltd. NADA for veterinary prescription use of eprinomectin by injection for trea...

Guidance on IVDs to Detect Human Papillomaviruses

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Federal Register Notice: FDA releases a guidance, establishing the performance characteristics of in vivo diagnostic devices for d...

Takeda NDA for Combo Diabetes Therapy

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Takeda files an NDA for alogliptin/metformin, a fixed-dose combination therapy for treating patients with Type 2 diabetes.

WLF Sides with Par on First Amendment Scuffle with FDA

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The Washington Legal Foundation says Par Pharmaceuticals has a good chance of prevailing in its recent First Amendment suit agains...

Comments Sought on Tobacco Retailer Training

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Federal Register Notice: FDA seeks comments on information collection provisions of a draft guidance on tobacco retailer training ...

OMB OKs Info on Biologic AERs

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on adverse experience repor...

Guidance on Radiopharmaceutical Late Radiation Tox Studies

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A new FDA guidance provides recommendations for designing nonclinical late radiation toxicity studies to determine potential late ...