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FDA Opioid Decision Favors Pharma Industry: Public Citizen

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Public Citizen accuses FDA of favoring the pharmaceutical industrys interests over protecting public health when it ordered class-...

Universal Flu Vaccine May Cause Problems

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Research conducted by FDA and USDA suggests that efforts to develop a universal flu vaccine could trigger antibodies that enhance ...

Stakeholders Suggest Improvements to Agency Communications

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Stakeholders say that FDAs report on communicating with under-represented subpopulations lacks specific actions and misses the mar...

Sunovion and Pfizer Behind in Peds Studies: FDA

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FDA says Sunovion and Pfizer have not met deadlines for submitting pediatric studies for their Xopenex and Protonix IV.

Info on Postmarket Surveillance Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on postmarket surveillance to the Office of Management a...

Comments Sought on Symbols on IVD Labels

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Federal Register Notice: FDA seeks comments on reporting requirements for educational outreach to support use of symbols on labels...

Info on Youth Tobacco Campaigns Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on youth tobacco prevention campaigns to the Office of M...

Ex-commissioner Frank Young Joins Braeburn Pharmaceuticals

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Former FDA commissioner Frank E. Young joins Braeburn Pharmaceuticals as executive vice president for clinical and regulatory affa...

Hamburg Updates Regulatory Science Efforts

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FDA commissioner Margaret Hamburg describes the agencys pioneering work in nanotechnology as part of its regulatory science effort...

Workshop on Clinical Trials and FDA Interaction

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Federal Register Notice: FDA plans a public workshop 11/6-7 to help the clinical research professional understand clinical trial r...