FDA's PROPOSED IND REPORTING REQUIREMENTS SHOULD BE LIMITED TO POTENTIALLY TOXIC DRUGS OR NOVEL NEW ENTITIES, FIRMS SAY; RESEARCH MAY BE AFFECTED
Executive Summary
FDA's proposal to increase reporting requirements for investigational new drugs should apply only to drugs that are novel or are a potential safety risk, a number of companies suggested in comments to FDA. The comment period on FDA's Oct. 27 proposed rule ended Jan. 25.