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FDA Releases Biomedical Innovation Blueprint

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FDA commissioner Margaret Hamburg releases the agencys blueprint for driving medical product innovation.

Boston Scientific Begins OMEGA Trial Enrollment

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Boston Scientific Corp. begins enrolling patients in the OMEGA trial to evaluate the safety and effectiveness of its OMEGA Platinu...

FDA Declares Certain Preemption Statements Not Justified

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Federal Register Notification of preemption review: FDA determines that three FDA regulatory preambles refer to preemption stateme...

Comments Sought on Animal Generic Drug User Fee Form

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Federal Register Notice: FDA seeks comments on the information collection burden of the Animal Generic Drug User Fee Cover Sheet f...

Panel to Discuss Pediatric Use for 4 Oncology Products

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet to discuss pediatric development plans for four approved p...

FDA Repudiates Dan Troys Preemption Preamble

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FDA says its position on federal preemption of state failure-to-warn suits, crafted by Bush Administration chief counsel Dan Troy,...

Sterility Test Change Clarification Sought

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BIO asks FDA to clarify a provision in its proposal to amend biological product sterility test requirements.

ANDA 'Refuse-to-receive' Actions Double Since 2009

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CDER Office of Generic Drugs regulatory support manager Kwadwo Awuah says incomplete ANDA applications that are refused to be acce...

Info on In Vivo Radiopharmaceuticals Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on regulations for in vivo radiopharmaceuticals used for...

FDA Debars Martinez Seldon

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Federal Register Notice: FDA permanently debars Deborah Martinez Seldon from providing services to anyone with an approved or pend...