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FDA Draft Guidance on Drug Distributor Annual Reporting

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FDA releases a draft guidance on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Di...

FDA Clears Advaxis IND for Prostate Cancer Combo Therapy

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FDA clears an Advaxis IND application to conduct a Phase 1/2 clinical study to evaluate the combination of ADXS-PSA with Mercks Ke...

OtisMed, Ex-CEO Plead Guilty Over Unapproved Device

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OtisMed Corp. and its former chief executive officer enter guilty pleas to intentionally distributing knee replacement surgery cut...

FDA Approves New Indication for Amgens Xgeva

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FDA approves an Amgen supplemental BLA for a new indication for Xgeva (denosumab) treating hypercalcemia of malignancy that is re...

EMA Probes Data Integrity Issues at Indian CRO

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Several European Union member states suspend the marketing authorizations of medicines that have been authorized on the basis of s...

FDA Notice of Commissioning of State/Local Officials

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Federal Register Notice: FDA publishes notice of FDA Commissioning of State and Local Officials, HHS/FDA/ORA with information ab...

FDA Sends Collection of Info on Tobacco Data to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the generic clearance for the collection of tobacco d...

Appeals Court Upholds Dismissal of Enbrel Biosimilar Challenge

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The Federal Circuit Court Of Appeals upholds a lower court ruling that found it premature for Sandoz to obtain a declaratory judgm...

FDA Approves Wraser Pharm Trezix for Pain Usage

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FDA approves a Wraser Pharmaceuticals NDA for Trezix (acetaminophen/caffeine/dihydrocodeine bitartrate) capsules, indicated for pa...

Fewer FDA-483s Issued in FY 2014

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FDA issues fewer FDA-483s in fiscal year 2014 than last year, according to just-released inspection data.