FDA and Drug Information Association Sponsoring September Workshop on FDA Critical Path Initiative

September 11, 2008

The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) and the Drug Information Association (DIA) are reminding interested stakeholders about a September 15-16 workshop in Bethesda, Md., on FDA's Critical Path Initiative.

The Critical Path Initiative is an FDA effort to modernize the science and tools used in the development, evaluation, manufacture and use of FDA-regulated products. Workshop participants will learn what has been accomplished under the initiative, the status of current projects, and future activities regarding human and veterinary drugs, human biologics, medical devices, and foods.

Food-related sessions at the workshop will include:

• Food Allergen Thresholds: Applications and Data Gaps
• Quantitative Structure Activity Relationship Analysis and Chemoinformatics Meet Human Health Effects and Food Additives
• Positioning US FDA in the International Regulatory Initiatives via the Computational Toxicology Program in CFSAN
• Where Molecular Epidemiology and Microbial Forensics Meet for Food Safety
• Developing a Framework for Biomarker Qualification for Chronic Disease Risk
  

Breakout sessions will feature specialists from CFSAN as well as other FDA Centers. End-of-day roundtables will be led by FDA Center Directors.

For more information about workshop topics and sessions, and to register for the workshop, please visit the DIA web site (PDF), or contact Kathleen Donner at the Drug Information Association's office at 215-293-5810 or at Kathleen.Donner@diahome.org.