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CDER Data Standards Quarterly Report Out

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CDER issues its latest drug standards program quarterly progress report.

Protonix Withdrawn for Safety Reasons: FDA

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FDA denies two petitions asking it to find that Wyeths original formulation of Protonix IV was not withdrawn for reasons of safety...

Pfizer Positive Trial Results with Herceptin Biosimilar

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Pfizer says its pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of biosimilar candidate PF-05280014 ve...

July User Fee Date for Sickle Cell Drug

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FDA sets a user fee review goal date of 7/7/2017 for an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade ...

FDA Sets New Import Data Requirements

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FDA deputy commissioner Howard Sklamberg outlines a new final rule with data submission requirements for importers of FDA-regulate...

FDA Cites 2 Pharmacy Compounding Operations

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FDA cites Prescription Lab Compounding Pharmacy and Stonegate Pharmacy in two recent Warning Letters as part of FDAs increased scr...

House Passes Cures Act, Sans Device Reporting Measure

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A day before the House passes it, a key committee denies a request by Rep. Louise Slaughter (D-NY) to add an amendment to the 21st...

Restrictions Sought on Generic Naloxone Products

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Adapt Pharma Operations asks FDA not to approve ANDA for generic forms of Narcan until the agency has evaluated and implemented ph...

FDA Denies Vanda Petition to Delay Generic Fanapt

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FDA denies a Vanda petition asking that it not approve an ANDA for Fanapt until expiration of a three-year exclusivity relating to...

Trump Taps Rep. Price as HHS Nominee

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President-elect Donald Trump selects House Budget Committee chair Tom Price (R-GA) to serve as HHS secretary in the next administr...