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FDA Approves Glaxos Anoro Ellipta to Treat COPD

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FDA approves GlaxoSmithKlines new combination COPD drug Anoro Ellipta.

Medication Guides Updated for 22 Drugs

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FDA lists 22 drugs for which Medication Guides have been updated.

GSK Radically Changes Drug Marketing

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GlaxoSmithKline announces significant changes to marketing practices, including not based sale representative compensation on the ...

FDA ADHD Drug Warning on Painful Erections

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FDA orders a new warning on certain attention deficit hyperactivity disorder drugs because in rare instances they cause prolonged ...

Authors Call for Major Changes in FDA Operations

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Harvard University researchers say FDAs methods of operations and funding should be radically overhauled to keep patients from bei...

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.