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Guidance on Age, Race Data in Device Clinical Studies

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FDA issues a final guidance on Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.

Vaccines Panel To Discuss 2018 Flu Vaccine

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Federal Register notice: FDA announces a 10/4 Vaccines and Related Biological Products Advisory Committee meeting.

Novartis Wins Priority Review Voucher for Kymriah Approval

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FDA issues Novartis a priority review voucher after approving qualifying rare disease product Kymriah (tisagenlecleucel).

FDA Seeks Comments on Reducing Regulation Burden

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Federal Register multiple notices: FDA seeks comments to help it identify existing regulations and related paperwork requirements ...

FDA Gets Funding Until 12/8 Under Emergency Disaster Bill

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The House and Senate approve a bill that provides funding for FDA and other government agencies until 12/8, as well as emergency d...

Workshop on Self-collection Devices for Pap Testing

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Federal Register notice: FDA announces a 1/11/2018 public workshop entitled Self-Collection Devices for Pap Test that will obtain ...

Expedited Drugs Have More Safety Labeling Issues: Study

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A new study in The BMJ finds an association between expedited drug development and review pathways and the likelihood of subsequen...

FDA Clears Spinal Resources Pedicle Screw

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FDA clears a Spinal Resources 510(k) for its Swedge Pedicle Screw System.

Deny PMRS RoxyBond Petition Quickly: Daiichi

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Daiichi Sankyo calls on FDA to promptly deny a Pharmaceutical Manufacturing Research Services petition asking the agency to stay t...

Verastem Reports Positive Phase 3 DUO Results

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Verastem says it plans a 2018 NDA for duvelisib following positive top line results in the DUO trial in patients with relapsed or ...