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Guidance on Tropical Disease Priority Review

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on tropical disease priority review vouchers.

Washington Spreading the Wealth to Drug Makers, He Says

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Washington attorney Jonathan Emord publishes a book, The Rise of Tyranny, which lambastes FDAs capture by the drug industry and th...

FDA Extends Review on GERD Drug

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FDA tells Takeda Pharmaceutical that it will need three additional months to complete its review on a NDA for TAK-390MR, indicated...

FDA Complete Response on Abbott Pain Killer

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FDA issues Abbott a complete response letter on an NDA for a controlled-release form of hydrocodone with acetaminophen.

Drug Companies Ready for Web 2.0?

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Digital markers say drug companies need to re-think their fear of using interactive features on Web sites.

FDA Delays Review on Fibromyalgia NDA

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FDA delays a review action date on Forest Laboratories and Cypress Biosciences NDA for milnacipran, indicated for treating fibromy...

FDA Complete Response on Ferumoxytol NDA

[ Price : $8.95]

FDA issues Amag Pharmaceuticals a complete response letter for ferumoxytol, indicated for treating iron deficiency anemia in chron...