FDA REOPENS COMMENT PERIOD FOR TWO ICH GUIDANCES

Prompted by a request from Wyeth, the FDA has reopened the public comment period for two International Conference on Harmonisation (ICH) draft guidances that assess possible cardiac risks associated with new drugs.

The comment period for the guidances closed Dec. 13, 2004, but the agency announced in the Jan. 5 Federal Register that the period has been extended until Feb. 13. Wyeth submitted a letter to the agency last month requesting the comment extension. The guidances were originally published in the Federal Register on Sept. 13, 2004.

The ICH guidances addressed in the announcement are titled, "S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals" and "E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs."

The S7B guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. It also includes information concerning nonclinical assays and an integrated risk assessment.The draft guidance is intended to facilitate the nonclinical assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk. The E14 guidance provides recommendations to sponsors concerning clinical studies to assess the potential of a new drug to cause cardiac arrhythmias.

To view the FDA's announcement, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/cd04163.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/cd04163.pdf).