Regulatory Roundup: FDA Issues Data On Drug-Induced Liver Injuries And Serious Skin Reactions; IPEC Federation Week Starts In France.

February 25, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA issues data on drug-induced liver injuries and serious skin reactions; IPEC Federation Week starts in France.

Regulatory Roundup

The US Food and Drug Administration and the International Serious Adverse Event Consortium have issued the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs). The data focus on the genetics associated with DILI and SSR and may help researchers better predict an individual’s risk of developing these serious complications, according to a Feb. 19, 2010 FDA release. The new research data complement previous releases of data in December 2008 and May 2009. “The continued accumulation of scientific information on the genetic basis of adverse drug events provides researchers with invaluable tools for understanding why some people respond to medicines differently than others," said ShaAvhree Buckman, MD, PhD, director of the Office of Translational Sciences in the FDA’s Center for Drug Evaluation and Research, in the release.

The International Pharmaceutical Excipients Council (IPEC) officially launched the IPEC Federation last week in Cannes, France. The federation represents IPEC-Americas, IPEC-Europe, IPEC-Japan, and IPEC-China and will work to promote a unified voice for the use of excipients in pharmaceuticals. Patricia Rafidison of IPEC Europe has been named chair of the Federation. Janeen Skutnik of IPEC-Americas will serve as vice-chair. The next meeting of the IPEC Federation will be held in Tallin (Estonia) in June 2010.