Panel at DIA Annual Meeting to explore evidentiary standards and regulatory hurdles

A forum on “FDA Programs to Encourage Innovation: Maximizing the Opportunities and Confronting the Challenges of New Product Development” will take place on June 17 at 10:30 a.m. as part of the DIA 2014 50th Annual Meeting at the San Diego Convention Center.

As FDA promotes its initiatives to add flexibility to the drug approval process, scholars scrutinize their real-world impact on research and development.

“FDA must change evidentiary standards to encourage innovation,” said Coleen Klasmeier, chairwoman of the forum and global coordinator for the food, drug and medical device regulatory practice at Sidley Austin LLP in Washington, D.C.

Klasmeier and a colleague examined 300 cases of new drug and biological approvals over 10 years. They found that FDA used the traditional two-trial standard in 90 percent of cases, and the more flexible one-trial standard in just 10 percent of cases.

“There’s no guarantee of consistent treatment…and it’s unclear which standard the FDA is using,” Klasmeier said.

“New product development and the FDA approval process are of critical importance to DIA stakeholders,” said DIA Global Chief Executive Barbara L. Kunz. “We look forward to a robust discussion at the forum from a variety of perspectives.” 

The panel will feature Carl Peck, adjunct professor in the Department of Bioengineering and Therapeutic Sciences at the University of California, San Francisco, and chairman of NDA Partners LLC, and Frank J. Sasinowski, director at Hyman, Phelps & McNamara, P.C.

Contact: Tiffany Cohen
+1 202.499.4411
tcohen@reingold.com

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