U.S., EU Officials Provide Update on Parallel Scientific Advice Pilot

June 19, 2006

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-20-2006, Volume 0, Issue 0

Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.

Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.

A U.S.- EU confidentiality agreement, which was finalized in 2003, provides a legal basis for the two regulatory agencies to discuss clinical protocols and development programs for investigational products. So far, the two agencies have held eight meetings to discuss specific scientific issues raised by industry sponsors, explained EMEA Executive Director Thomas Lonngren, Pharm, MSc. Although FDA and EMEA officials issue separate letters presenting their views on the issue raised, there has been little disagreement between the two agencies so far, commented Murray Lumpkin, MD, MSc, FDA deputy commission for international and special programs.

He noted that this pilot advisory program is most suitable for resolving specific issues involving new technologies that lack extensive guidance or regulatory experience. The two regulatory agencies agreed at a March 2006 meeting in Brussels to continue the pilot while evaluating its value and future development. While these joint meetings are highly resource intensive, they would like to overcome an apparent reluctance of sponsors to seek advice on highly controversial issues.

— Jill Wechsler

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