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Progress in PDUFA 6 Talks

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FDA releases minutes describing progress made during discussions with industry at three PDUFA 6 steering committee meetings and on...

Dignitana Cooling Cap Cleared for Reducing Chemo Hair Loss

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FDA clears a Dignitana de novo petition to allow marketing of the DigniCap Cooling System, a cooling cap designed to reduce hair l...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Applied Nutriceuticals, DBM Nutrition, ICF International, Medisca Pharmaceutique...

Pfizer Awards $4 Million for Breast Cancer Research

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Pfizer says it has awarded five grants totaling more than $4 million under its inaugural Advancing Science through Pfizer Investig...

Pfizer sNDA for Xalfori Accepted for Priority Review

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FDA accepts for priority review a Pfizer supplemental NDA for Xalkori (crizotinib) for treating patients with metastatic non-small...

FDA Guidance on Surgical Gowns

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FDA issues a guidance on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings that descri...

FDA Approves Alexions Kanuma for Rare Disease

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FDA approves an Alexion Pharmaceuticals BLA for Kanuma (sebelipase alfa), the first treatment for patients with the rare disease l...

FDA Clears Battlefield Wound Dressing for Civilian Use

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FDA clears a RevMedX 510(k) for the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-thr...

FDA Panel to Review Codeine Safety in Children

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FDA convenes a joint meeting of its Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Commit...

Court Tries to Define Clear Evidence in Preemption Case

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Attorney Emily Pincow says that a California federal court ruled that there can be clear evidence that FDA would reject a proposed...