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Dont Take Ear Candlers Warning Letter Case: FDA

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FDA asks the Supreme Court not to hear a case brought by five ear candle manufacturers who claim that agency Warning Letters are f...

FDA Backs Class 2 for Spinal Screw Systems

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FDA says it agrees with the Orthopedic Special Manufacturers Association that posterior cervical screws should be Class 2.

FDA Panel to Discuss Celgene NDA for Multiple Myeloma

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FDAs Oncologic Drugs Advisory Committee will meet 11/8 to discuss a Celgene Corp. NDA for pomalidomide for use in combination with...

FDA OKs InnoPharma ANDA for Lung Diseases

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FDA approves an InnoPharma Inc. ANDA for acetylcysteine solution, USP 20% as adjuvant therapy for patients with certain lung disea...

Researchers Working on Better Hip Replacement Metal

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Researchers report in an American Chemical Society publication they are making progress in findings ways to use tantalum as a hip ...

Research Favors Genetic Model for PK/PD Testing

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Janssen Biotech files a BLA seeking approval for an investigational intravenous formulation Simponi for treating adults with moder...

FDA Removes Warning for Cattle Feed

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Federal Register Final rule: FDA amends the animal drug regulations to remove a warning for growing cattle and to codify all monen...

FDA Corrects Notice on Tobacco Establishment Registration

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Federal Register Notice: FDA corrects a 5/3 Federal Register notice on registration and product listing for tobacco product establ...

FDA Corrects Notice on Tobacco Ingredients

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Federal Register Notice: FDA corrects form numbers in an 8/3 Federal Register notice on tobacco product ingredients listings.

Bedford Laboratories Expands Leucovorin Recall

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Bedford expands its recall of liquid leucovorin calcium injection to include all lots within expiry due to the potential for cryst...