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Comments Sought on DTC Drug Study

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a proposed collection of information on a study designed to use eye tracking techno...

Info on Animal Drugs for Minor Use/Species Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on designated new animal drugs for minor use and minor s...

FDA Clears Upgraded HammerLock Fixation System

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FDA clears a BioMedical Enterprises 510(k) for an upgrade to its HammerLock Nitinol Intramedullary Fixation System.

FDA Clear Elekta Treatment Planning System

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FDA clears an Elekta 510(k) for the Monaco 5, the latest version of its Monaco treatment planning system.

FDA Study Finds Gaps in Pertussis Vaccine Protection

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FDA researchers say acellular pertussis vaccines are effective in preventing disease but not as effective in preventing infection ...

FDA Follows Advisors Votes 86% of the Time: Study

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A McKinsey analysis finds that FDA follows recommendations of advisory committees to approve or not approve an NDA or BLA nearly 9...

Priority Review for Durata NDA for Skin Infections

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FDA accepts for priority review a Durata Therapeutics NDA for Dalvance (dalbavancin hydrochloride) for injection for treating pati...

FDA Fast Track for VBL Brain Cancer Drug

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FDA grants VBL Therapeutics a fast track designation for its lead oncology drug VB-111 and its use in prolonging survival in patie...

FDA Asked for New Homeopathic Drug Marketing Rules

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Former FDA Office of Regulatory Affairs manager William Schwemer asks FDA to issue new rules governing marketing of homeopathic dr...

FDA Hits 2nd Wockhardt Plant with Import Alert

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FDA issues an import alert for most generic drugs manufactured at Wockhardts Chikalthana facility.