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Doctors See Industry-funded Trials as Less Credible

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Researchers find that doctors think industry-funded research is less credible than trials funded by NIH.

OPDP Finds Multiple Problems in FazaClo Brochure

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CDERs Office of Prescription Drug Promotion warns Jazz Pharmaceuticals about a FazaClo patient brochure that it says suggests that...

Tighten Fraud Settlements: Professor

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Law school professor Kevin Outterson says Congress should consider ways to strengthen penalties imposed on companies and their exe...

ORA Headquarters Reorganizing

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ORA says its headquarters reorganization better positions it to work in the new global healthcare environment facing FDA.

Sanofi Collaborates to Develop New TB Treatments

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Sanofi and the Global Alliance for TB Drug Development sign a research collaboration agreement to discover and develop novel compo...

Guidance on Pentosan Polysulfate Sodium BE

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Federal Register Notice: FDA releases a draft guidance, Bioequivalence Recommendations for Pentosan Polysulfate Sodium.

Panel to Discuss Myeloma and Iron Overload Treatments

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 11/8 to discuss a Celgene NDA to treat mulitple myeloma...

Panel to Discuss Theravance NDA for Pneumonia Treatment

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 11/29 to discuss a Theravance NDA for Vivativ for ...

FDA OKs Acton Pharma sNDA for Asthma

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FDA approves an Acton Pharmaceuticals sNDA for Aerospan Inhalation indicated for the maintenance treatment of asthma as a prophyla...

FDA Clears Intelomed 510(k) for CVInsight

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FDA clears an Intelomed, Inc. 510(k) for its CVInsight device that measures and displays a patients vital signs and cardiovascular...