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Comments Sought on Animal Drug User Fee Cover Sheet

[ Price : $8.95]

Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection related to requi...

Alkermes Reports Positive Data on Depression Drug

[ Price : $8.95]

Alkermes releases positive topline results from FORWARD-5, a third Phase 3 efficacy study of ALKS 5461, a once-daily, oral investi...

Comments Sought on Dear Doctor Letters

[ Price : $8.95]

Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection related to a gui...

Teva Resubmits NDA for Huntingtons Drug

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Teva Pharmaceutical Industries refiles an NDA for SD-809 (deutetrabenazine) for treating chorea associated with Huntington disease...

Teleflex Recalls Tracheostomy Tube Set

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Teleflex Medical begins a Class 1 recall of its Willy Rusch Tracheostomy Tube Set which are used for cannulation of tracheotomized...

FDA Orphan Designation for Alexion Drug Candidate

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FDA grants Alexion Pharmaceuticals an orphan drug designation for ALXN1007, a novel anti-inflammatory monoclonal antibody targetin...

Stop Using Multidata Radiation Therapy Devices: FDA

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FDA urges healthcare providers and facilities to stop using any Multidata Systems radiation therapy devices because they were neve...

Old Court Case Scores Preemption Win

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Attorney John Sullivan praises a 2014 Georgia federal court decision that supported preemption of state failure-to-warn claims aga...

Califf: He and Woodcock were Right on Duchenne Drug Approval

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Amid growing controversy, FDA commissioner Robert Califf says he was right in upholding her action, and by extension CDER director...

Advisors Suggest Narrower Desmopressin Indication

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Members of the FDA Bone, Reproductive, and Urologic Drugs Advisory Committee recommend approval of Serenitys desmopressin nasal sp...