Center for Drug Evaluation and Research Office of New Drugs Novel Excipient Review Pilot Program

Resumen

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing a Novel Excipient Review Pilot Program (Pilot Program). The Pilot Program is voluntary and intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. The Pilot Program seeks to foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients.