ANTI-ANGINAL GUIDELINES NEED NOT AGREE WITH EC DRAFT, ADVISORY COMMITTEE SAYS; RECOMMENDS WORKSHOP TO DETERMINE EARLY STAGE ISSUES IN DRUG DEVELOPMENT
Executive Summary
FDA should convene a workshop to discuss issues of dose-response and selection in clinical development, FDA Cardiovascular & Renal Drugs Advisory Committee temporary member Craig Pratt, MD, Methodist Hospital (Houston), suggested during the panel's discussion of anti-anginal drug development guidelines Feb. 24.