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Company Marketing Unapproved Drug Abuse Test

[ Price : $8.95]

FDA warns American Bio Medica that it is selling an unapproved OTC drug abuse test for public use in workplaces.

FDA Clears New Boston Scientific Biliary Stents

[ Price : $8.95]

FDA clears a Boston Scientific 510(k) for the WallFlex Biliary RX fully and partially covered stents for the palliative treatment ...

List of Approved PMAs Posted

[ Price : $8.95]

Federal Register Notice: FDA publishes a list of approved PMAs.

Panel to Discuss Novartis NDA

[ Price : $8.95]

Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 12/7 to discuss Novartis NDA for everoli...

Panel to Discuss Spine System

[ Price : $8.95]

Federal Register Notice: FDAs Orthopedic and Rehabilitation Device Panel will meet 11/4 to discuss Zimmer Spines PMA for the Dynes...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Bio Medica, Mountain Meadow Herbs, Phoenix Medical Devices and Weartech...

FDA Grants Humanitarian Status for Cryolife Aortic Valve

[ Price : $8.95]

FDA grants CryoLife Inc. a humanitarian-use device designation for the CryoValve SG aortic human heart valve.

Court Rejects Preemption in a Generic Drug Case

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A New Hampshire federal judge says that federal law doesnt preempt state tort claims brought against Mutual Pharmaceutical by a wo...

FDA Media Access Policy Unconstitutional Editor Says

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FDA Webview editor Jim Dickinson says in a petition to the agency that its current media access policy is unconstitutional and ask...

FDA Sees No New Safety Signals in Selzentry New Indication

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FDA asks the Antiviral Drugs Advisory Committee whether Pfizers Selzentry is safe and effective for use with treatment-nave HIV-1 ...