September 8, 2003

Steven Gutman, MD, and Joseph Hackett, PhD.

Join us starting on September 8, 2003, at 1:00 p.m. Eastern time for a week-long SPECIAL EDITION of AACC Expert Access Live Online featuring Steven Gutman, MD, and Joseph Hackett, PhD, from the FDA’s Center for Devices and Radiologic Health, discuss “FDA and the Regulation of Analyte Specific Reagents.”

The FDA wants your help!! In 1997 the agency published a new rule, called the Analyte Specific Reagent (ASR) Rule, which put into place incremental increases in regulatory requirements for both manufacturers and laboratories. In 2001 the Secretary’s Advisory Committee on Genetic Testing (SACGT) produced a report recommending that FDA apply its pre-market review process to new ASR-based genetic tests.

SCGT has now been replaced by Secretary’s Advisory Committee on Genetics, Health, and Society, but the recommendations made by SACGT remain on the table. As a result, FDA is now working on a “Notice of Proposed Rule Making” and seeking comments that will help them determine whether genetics tests have a risk profile that might warrant additional oversight through changes in the ASR rule.

What do you think? Join us the week of September 8 for your opportunity to address comments and questions directly to FDA thought leaders who will be overseeing the rulemaking process!!