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FDA Approves Novartis Combo Bronchodilator COPD

[ Price : $8.95]

FDA approves a Novartis NDA for its dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powde...

NEJM Editorial Backs Califf as Next FDA Commissioner

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A New England Journal of Medicine (NEJM) editorial throws support behind FDA Office of Medical Products and Tobacco deputy commiss...

FDA Approves Expanded Use in Melanoma for BMS Yervoy

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FDA approves an expanded use for Bristol-Myers Squibbs Yervoy (ipilimumab) adjuvant therapy for patients with Stage III melanoma ...

OMB OKs Info on Outsourcing Facilities

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Federal Register Notice: The Office of Management and Budget approves a collection on information on a guidance on adverse event r...

FDA Issues Revised Liposome Guidance

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FDA issues a revised guidance on information needed with an application for liposome drug products reviewed by CDER.

FDA Extends Dispenser Tracing Info Deadline

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FDA revises a product tracing compliance guidance to give more time before it takes enforcement action against drug dispensers who...

Stakeholders Appreciate Registry Report

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Stakeholders say they generally support a Medical Device Registries Task Force report on a national medical device evaluation syst...

Researchers Working on Heart-powered Pacemaker

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University of Buffalo engineering researchers say they are building a prototype of a pacemaker that would operate without batterie...

Docket Established for Input on Technologies in Clinical Trials

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Federal Register Notice: FDA establishes a public docket to solicit input on the use of technologies and innovation in conducting ...

CDER Network of Experts MAPP Out

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CDER issues a MAPP on using the Centers Network of Experts.