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2 Devices OKd to Assess Cognitive Function After Brain Injury

[ Price : $8.95]

FDA approves an ImPACT Applications de novo petition to allow the marketing of two new devices to assess a patients cognitive func...

FDA Fast Track for Lilly/AstraZeneca Alzheimers Drug

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FDA grants Eli Lilly and AstraZeneca a fast track designation for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor...

Honeywell Recalls Eyesaline Eyewash Due to Contamination Concern

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Honeywell recalls one lot of its 32-ounce Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury, bec...

Kindred Bio Submits NADA Section for Overweight Cats

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Kindred Biosciences files the effectiveness technical section of a New Animal Drug Application for Mirataz (mirtazapine transderma...

Info on Device Exports Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the export of medical devices to the Office of Manage...

CDRH Outlines Requests for Alternative UDI Approaches

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CDRH updates its Web page on requests for an exception to use an alternative approach to meet requirements under the agencys Uniqu...

Sagent Recalls Antibiotic Due to Particulate Matter

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Sagent Pharmaceuticals recalls one lot of oxacillin for injection 10g, which was manufactured by Astral SteriTech, due to a produc...

FDA Approves Expanded Use for Edwards Heart Valves

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FDA approves an expanded indication for Edwards Lifesciences Sapien XT and Sapien 3 transcatheter heart valves for patients with a...

FDA Grants Supernus Tentative Approval on Trokendi

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FDA grants Supernus Pharmaceuticals tentative approval for an sNDA requesting a label expansion for Trokendi (topiramate) XR to in...

Info on Mammography Standards Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on the Mammograph...