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FDA Targeting Incurred Sample Reanalysis in BIMO Inspections

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CDER Division of Scientific Investigations associate director C.T. Viswanathan says recent BIMO inspections have been citing defic...

Assess Safety of Sunscreen Nanoparticles: CU

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Consumers Union calls on FDA to make a safety assessment of titanium oxide and zinc oxide nanoparticles used in many sunscreens.

FDA OKs Merial sNADA for Canine Postoperative Pain

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Federal Register Final rule: FDA approves a Merial sNADA for providing veterinary prescription use of firocoxib chewable tablets i...

FDA Approves Schwarz Toviaz for Overactive Bladder

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FDA approves Schwarz Pharmas Toviaz for treating overactive bladder.

Secretive FDA Safety Board Discusses ESAs

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CDERs secretive Drug Safety Oversight Board says it discussed use of erythropoiesis stimulating agents in treating ischemic stroke...

Woodcock Has Generic Skepticism as a Top Priority

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CDER director Janet Woodcock tells a generic drug conference that one of her top priorities for the Center is to address the risin...

FDA OKs New Use for Hospiras Precedex

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FDA approves a new indication for Hospiras Precedex, allowing for the drugs in-hospital use in non-intubated patients requiring se...

FDA Accepts Erbitux sBLA for Expanded Indication

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FDA accepts for review an Imclone and Bristol-Myers Squibb supplemental BLA seeking to broaden the indication for Erbitux.