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OMB OKs Info on Exemption for Preemption

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on state petitions for exemption...

FDA Permanently Debars Reuben

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Federal Register Notice: FDA issues an order permanently debarring Scott S. Reuben, MD from providing services to anyone with an a...

Date Corrected in Guidance Notice

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Federal Register Notice: FDA corrects a date in a Federal Register notice announcing a draft guidance on the Electronic Transmissi...

Comments on Allergic Disease Treatment Extended

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Federal Register Notice: FDA extends the comment period on a scientific and medical literature report on the use of non-standardiz...

Panel to Discuss Cranial Electrotherapy Device Reclassification

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Federal Register Notice: FDAs Neurological Devices Panel will discuss 2/10/12 the possible reclassification of cranial electrother...

Woodcock Optimistic on Startlingly Better Therapies

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CDER director Janet Woodcock says she is so optimistic that the 40 years of biomedical science and the war on cancer will be produ...

FDA Dodges Bullet in House/Senate Funding Agreement

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FDA dodges a funding bullet as House and Senate conferees agree to follow the Senates version of the agencys FY 2012 appropriation...

Sen. Franken Introduces Device Reform Bill

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Sen. Al Franken (D-MN) introduces the Patient Access to Medical Innovation Act to get innovative medical devices to market more qu...

FDA Clears Calix PC Spinal Implant System

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FDA clears an X-Spine 510(k) for the Calix PC Spinal Implant System, an intervertebral body fusion system.

Distribution of Pennsaid Samples Stopped

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FDA asks Mallinckrodt to stop distributing 15 mL sample bottles of Pennsaid due to reports of improper administration by patients.