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FDA Asks for More Data on Clovis Lung Cancer Drug

[ Price : $8.95]

FDA requests additional efficacy clinical data as part of its review of an NDA for rociletinib (500mg and 625mg BID), indicated fo...

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...

FDA Corrects Final Rule on Tobacco Product Marketing

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Federal Register Notice: FDA corrects certain reference numbers in the preamble to a 9/24 final rule on environmental assessments ...

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Hearings for Nitroglycerin in Transdermal Systems Withdrawn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.