Ethics/Regulatory

BRANY earns five-year AAHRPP accreditation

Wednesday, March 18, 2015

BRANY has successfully continued its full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The five-year accreditation reflects BRANY’s continuing commitment to protecting the rights and welfare of research participants. AAHRPP’s accreditation process helps organizations consistently meet ethical principles and standards for protecting research participants.

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FDA launches drug shortages mobile app

Thursday, March 5, 2015

The FDA has launched the agency’s first mobile application specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

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Regulatory Update, March 2015

Sunday, March 1, 2015

FDA guidance on developing vaginal Microbicides for Preventing HIV Infection

The FDA has announced the availability of a guidance document titled Vaginal Microbicides: Development for the Prevention of HIV Infection. The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides, defined as vaginal drug products that prevent human immunodeficiency virus (HIV) acquisition.

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Pearl IRB granted AAHRPP accreditation

Thursday, February 26, 2015

Pearl IRB, an Indianapolis-based provider of central IRB review services, has received accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

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