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Insys Gets Fast Track for Potential EpiPen Rival

[ Price : $8.95]

FDA grants Insys Therapeutics a fast track designation for its epinephrine nasal spray as an investigational treatment for anaphyl...

Pull Shared System REMS Guidance: NACDS

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Chain drug stores urge FDA to withdraw a draft guidance on waivers for single, shared system REMS, and other stakeholders also cri...

CDER Statisticians Tout Flexible Trial Designs

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An online CDER post describes work of Center statistical researchers in developing complex innovative clinical trial designs.

FDA Modernizing Regulation Approach: Gottlieb

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FDA commissioner Scott Gottlieb says the agency is modernizing its approach to medical product regulation to support innovation in...

Sexual Enhancement Product Permanent Injunction

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The New Jersey federal court approves a permanent injunction sought by FDA against several companies and their executives charged ...

Auris Medical Get FDA Buy-in for Pivotal Trial

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FDA approves Auris Medicals proposed choice of primary and secondary efficacy endpoints for a pivotal Phase 3 trial of AM-111 (bri...

FDA Approves 2 Merck HIV-1 Drugs

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FDA approves two Merck NDAs for human immunodeficiency virus (HIV)-1 drugs Delstrigo and Pifeltro.

Bipartisan Prescription Safety Alert Bill

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Three House members introduce legislation to create a prescription drug safety alert system to give drug dispensers patient inform...

Researchers Urge Stricter Breakthrough Device Reviews

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Researchers say FDA should issue time-limited breakthrough device approvals with mandated period review of a devices safety and ef...

Ultragenyx Gets FDA Nod to File UX007 NDA

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FDA accepts an Ultragenyx Pharmaceutical proposal to submit an NDA for UX007 for treating long-chain fatty acid oxidation disorder...