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Efforts to Make FDA Approval Packages More Helpful

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OpenTrialsFDA app developers say they are working on ways to make agency drug approval packages more useful in informing evidence-...

Pharmacist Guilty in Black Market Meds Scheme

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A New York state court finds pharmacist Ira Gross and his shell company, Chaparral Services, guilty of distributing HIV medication...

Tysabri Negligence Case Dismissed

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A Utah federal court grants summary judgment on several grounds and dismisses a negligence case against Biogen Idec and Elan over ...

PharmaTech Recalls All Liquid Products

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FDA says that PharmaTech has expanded its recall from Diocto Liquid to cover all of its liquid products manufactured in Davie, FL....

AstraZeneca Says Lung Cancer Trial Misses Endpoint

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AstraZeneca reports disappointing results from a Phase 3 trial (SELECT-1) of its MEK 1/2 inhibitor, selumetinib, in combination wi...

FDA Clears Centric Medical Hammertoe Device

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FDA clears a Centric Medical 510(k) for the Hammertoe Correction System.

FDA Priority Reviews for Marathon Duchenne NDAs

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FDA accepts for priority review two Marathon Pharmaceuticals NDAs for the investigational drug deflazacort one for an immediate-r...

FDA Emphasizing Data Integrity: Attorneys

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Two DLA Piper attorneys analyze the increasing FDA/Justice Department focus on cGMP compliance.

FDA Facilitating OTC Naloxone Applications

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CDERs Karen Mahoney says FDA is trying to help sponsors prepare OTC naloxone applications.

CDER To Issue Revised Draft Guidance on Quality Metrics

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CDER decides to scrap its 2015 new draft guidance on Request for Quality Metrics, and plans to replace it with a revised draft doc...