The U.S. Food and Drug Administration (FDA) has introduced a set of Qualification Programs which may facilitate drug development through novel tools. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) remarked that "the system of drug regulation needs to evolve so that new science, including advances in clinical trial design and acceptable endpoints, will rapidly translate into new regulatory methods."

CDER now has developed and introduced the so called Drug Development Tools (DDTs) Qualification Program. Qualification in this framework means "a conclusion that within the stated context of use, the DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review". The DDT Qualification Program shall foster collaboration and co-operation between industry, academia, government, and individual investigators, based on a voluntary basis.

As a start, three programs have been launched:

• Biomarker Qualification Program
• Clinical Outcome Assessment Qualification Program
• Animal Model Qualification Program

Please also see the information and detailed explanations of the Biomarker Qualification Programs.

Compiled by
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)