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Many Doctors Have Twitter Conflicts of Interest

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Oregon Health & Sciences University researchers say many hematologists and oncologists who frequently tweet cite drugs positively ...

Pilot Program on Early PMA Critical-to-Quality Controls

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FDA announces a pilot program on Approval Application Critical to Quality which aims to evaluate device design and manufacturing p...

Galena Bio Pays Fine in Kickback Case

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Galena Biopharma agrees to pay the federal government more than $7.55 million to resolve allegations under the civil False Claims ...

Janssen Scraps Hep C Therapy Due to Saturated Market

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Janssen Sciences discontinues development of its investigational hepatitis C treatment regimen JNJ-4178, a combination of three di...

Clinical Development Modernization Urged by Gottlieb

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FDA commissioner Scott Gottlieb says a top priority of his is to modernize how clinical information is collected and analyzed.

FDA Urges Industry Comments on Continuous Manufacturing

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FDA continues to urge the adoption of continuous manufacturing by drug manufacturers and seeks comments on the emerging field by 9...

FDA Accepts Adello BLA for Neupogen Biosimilar

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FDA accepts for review an Adello Biologics BLA for a biosimilar candidate referencing Amgens Neupogen (filgrastim), indicated for ...

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).