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NEWS ARCHIVE

Friday September 3, 2010

  • EMEA-FDA GCP Initiative
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  • FDA IRB Registration Rule
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  • Study data may be fake.
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  • Biosearch Moniotring Information System (BMIS) File.
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  • New Release -International Compilation of Human Research Protections 2009 Edition
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  • New FDA Draft Guidance document issued: Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting - Improving Human Subject Protection
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  • FDA Revises Clinical Investigator Compliance Program CP 7348.811
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  • FDA Bars Doctors from Drug Trials.
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  • OHRP Spanish Pamphlet Now Available
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