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Pfizer Settle with Teva for Generic Viagra in Late 2017

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Pfizer settles litigation against Teva Pharmaceuticals that will allow generic Viagra beginning 12/2017.

Guidance on Medical Device Pivotal Study Design Explained

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CDRHs Greg Campbell describes elements in the Centers final guidance on designing medical device pivotal clinical trials.

Human Cell Violations Found at Manhattan Reproductive

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FDAs New York District Office warns Manhattan Reproductive Health about violations of regulations governing human cells, tissues, ...

FDA, CMS Agree to Extend Parallel Review Pilot

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FDA and CMS say they are extending for two years a Pilot Program for Parallel Review of Medical Products.

FDA Wont Order Xenical and Alli Off Market

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FDA denies a Public Citizen petition asking that it pull Rx and OTC orlistat from the market for safety reasons.

Panel to Discuss Northera, Zontivity, Xarelto

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 1/14-16/14 to discuss Chelsea Therapeuti...

FDA Proposes Changes for OTC Consumer Antiseptic Washes

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Federal Register Proposed rule: FDA proposes to amend a 1994 monograph to establish conditions under which OTC consumer antiseptic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Stanislaw R. Burzynski, Burzynski Research Institute, Green Planet, Manhattan Re...

Public Citizen Complains About FDA Drug Compounding Position

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Public Citizen writes FDA asking it to stop making misleading statements about pharmacy compounding that could lead health care pr...

FDA Proposal Cracks Down on Antibacterial Soaps

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A just-released FDA proposed rule aims to require manufacturers of antibacterial hand soaps and body washes to demonstrate that th...