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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In appreciation: Karen Woodin will be remembered for her teaching, writing and lasting friendships

Monday, February 23, 2015

Karen Woodin, Ph.D., who passed away Feb. 8 after a long and distinguished career in the clinical research industry, is described as thoughtful and astute, with a blend of academic and artistic talents. Known widely for authoring two industry guides, her dynamic career also included a 20-year tenure at Upjohn and many years as a workshop leader, teacher and director of the Drug Information Association (DIA). She was 74 years old.

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Advanced eTMF systems offer CROs advantages

Sunday, February 15, 2015

It’s no secret competitive pressures are mounting for CROs. Life sciences companies need to get to market faster and more efficiently. Although sponsors are actively investing in CRO partnerships, they want to establish fewer, more strategic partners to improve efficiency. [Read More]