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Womens Health Initiatives Meeting for Nursing Prof/Students

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Federal Register Notice: FDA plans a meeting 11/8 on Office of Womens Health Update on Strategic Priorities and Initiatives of int...

Violations Noted in Cipla Inspection

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Indias Economic Times newspaper says that FDA inspectors found several violations in an inspection at Ciplas Indore manufacturing ...

Researchers Question FDA Cancer Approvals with Surrogate Endpoints

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Two researchers writing in JAMA Internal Medicine say FDA since 2008 has been approving a higher percentage than in the past of ca...

Quality System Violations at St. Jude Medical

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FDAs Atlanta District Office warns St. Jude Medical about Quality System violations at its CardioMEMS unit.

Federal Circuit Denies En Banc Hearing on Biosimilars

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The Federal Circuit Court of Appeals denies Amgen and Sandoz petitions for rehearing and rehearing en banc of their case against S...

Info on User Fee Cover Sheet Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the user fee cover sheet to the Office of Management ...

Comments Sought on Influenza A Reagent Guidance

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Federal Register Notice: FDA seeks comments on a guidance on reagents for detecting influenza A viruses.

Guidance on Drugs for E-coli in Cattle

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Federal Register Notice: FDA releases a guidance: Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic...

CDRHs Top 10 Regulatory Science Priorities

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A new CDRH regulatory science outline the top 10 priorities for 2016, including leveraging big data and evidence from clinical exp...

Hillary Clinton Asks FDA for Help With Drug Pricing Issue

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Democratic presidential candidate Hillary Clinton makes the escalating cost of certain drugs a campaign issue, as well as the need...