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8 Drug Companies Spend $220 Million on Physician Speakers

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A ProPublica analysis finds that eight drug companies paid physicians more than $220 million last year to act as promotional speak...

Sanaria Malaria Vaccine Trial Reports Positive Results

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Rockville, MD-based Sanaria reports positive results from a trial of its malaria vaccine in an online issue of Science.

Marshall Edwards Initiates Phase 1 Trial with Anti-Tumor Drug

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Marshall Edwards initiates a Phase 1 clinical trial of its drug candidate ME-143 in patients with refractory solid tumors.

CDRH Letter to Industry on Speeding Import Entries

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A CDRH letter to industry provides recommendations to help ease the FDA import entry review process for medical and non-medical ra...

Panel Backs J&J's Stroke Drug Xarelto

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An FDA advisory committee votes to recommend approval of a Janssen Pharmaceuticals NDA for its investigational drug Xarelto (rivar...

Ardea Bio Reaches Agreement on Phase 3 Gout Trial

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Ardea Biosciences completes formal end-of-Phase 2 meetings with FDA and reaches agreement on key aspects of a proposed Phase 2 tri...

Generic Firms May Send Some Dear Doctor Letters: Judge

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A Nevada judge says a Supreme Court decision in a generic drug preemption case doesnt stop companies from sending Dear Doctor lett...

FDA Approves Sagent's Generic Haldol

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FDA approves a Sagent Pharmaceuticals ANDA for haloperidol injection, a generic copy of Ortho-McNeil's antipsychotic Haldol.

CBER Says Fluzone Detail Aid is False, Misleading

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CBERs Advertising and Promotional Labeling Branch says that a Sanofi Pasteur Fluzone detail aid omits and minimizes important risk...

Comments Sought on Humanitarian Use Device Requirements

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Federal Register Notice: FDA seeks comments on the information collection requirements for humanitarian use devices.