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FDA Cancels Panel Meeting on Organ Perfusion System

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Federal Register Notice: FDA cancels the 11/18 Gastroenterology and Urology Devices Panel meeting and postpones the 11/19 session.

Rutgers-led Research to Focus on Continuous Manufacturing

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FDA awards $4.9 million in grant funding to the Rutgers University School of Engineering to support the introduction of continuous...

FDA Report Examines Laboratory-developed Test Accuracy

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A new FDA report examines how increased regulatory oversight is needed to ensure laboratory-developed tests (LDTs) to limit inaccu...

NY Times Editorial Seeks Answers to Califfs Industry Ties

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A New York Times editorial says a Senate Committee hearing 11/17 needs to grill FDA commissioner nominee Robert Califf on whether ...

CDRH Seeks Participants for Training Program

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Federal Register Notice: CDRH is seeking participants for its 2015 Experiential Learning Program General Training Program.

Hearings for Nitroglycerin in Transdermal Systems Withdrawn

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Federal Register Notice: FDA announces that all outstanding hearing requests on nitroglycerin drug products in transdermal systems...

FDA Plans Sentinel Initiative Public Workshop

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Federal Register Notice: FDA plans a public workshop 2/3/16: Eighth Annual Sentinel Initiative Public Workshop.

Nominations Sought for Tobacco Scientific Panel

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Federal Register Notice: FDA requests nominations for its Tobacco Products Scientific Advisory Committee.

Janssen Multiple Myeloma Drug Given Accelerated Approval

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FDA grants accelerated approval to a Janssen Biotech NDA for Darzalex (daratumumab) for treating patients with multiple myeloma wh...

Comments Sought on Harmful Tobacco Constituent Info

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Federal Register Notice: FDA seeks comments on a collection of information on the reporting of harmful constituents in tobacco pro...