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Gilead Asks 9th Circuit to Rehear HIV Drug Case

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Gilead, supported by the Washington Legal Foundation, asks the 9th Circuit Court of Appeals to rehear a False Claims Act case invo...

PMA Critical to Quality Pilot Program

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Federal Register notice: FDA announces a Premarket Approval Application Critical to Quality pilot program.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Dynavision International and HomeoCare Laboratories.

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 ...