FDA on Safety Information During Clinical Trials

BioSoteria, Inc., Drug Safety and Risk Management Specialists, continue to be at the forefront in responding to the recent announcement of the ruling by FDA on safety information during clinical trials. A recently published article co-authored by BioSoteria’s President & CEO, Sally Van Doren, PharmD and Senior Vice President of Pharmacovigilance and Risk Management, James Buchanan, PharmD, helps drug safety professionals and study sponsors navigate through the complex rule on the new investigational new drug (IND) safety reporting requirements during clinical trials.

The FDA has announced changes to the US regulations on IND safety reporting, which go into effect on March 28, 2011. To access the article and learn more about how these regulation changes will impact your clinical trial conduct and IND safety reporting practices, go to BioSoteria Publications to download this peer reviewed article with home study credits, “The New FDA Final Rule on IND Safety Reporting: Implications to Your Clinical Development Program or view the article in the April 2011 issue of the ACRP Monitor.

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