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FDA Publishes Investigator Responsibility Guidance

[ Price : $8.95]

FDA issues a guidance on the role of clinical investigators in conducting trials and protecting subjects rights, safety, and welfa...

Companies Report 3rd Rituxan PML Case

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Genentech and Biogen Idec say they have recorded the first case of a rheumatoid arthritis patient treated with Rituxan who develop...

FDA Questions Abthrax Data

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FDA tells the Anti-infective Drugs Advisory Committee that questions have come up about the reliability of Human Genome Sciences h...

FDA Approves Emergency Use for Peramivir

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FDA approves emergency use of the BioCryst IV investigational antiviral peramivir in hospitalized adult and pediatric patients wit...

FDA Failing to Track. Enforce Postmarketing Reports: GAO

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FDA rejects a Government Accounting Office recommendation that it clarify the conditions that would lead it to exercise regulatory...

Guidance on Investigator Protection of Subjects

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Federal Register Notice: FDA releases a guidance on clinical investigator responsibilities and protecting the rights, safety, and ...