Dates: Wednesday, October 27, 2021 - 17:00 CEST - 11:00 EDT
Join us for an overview of the Novel Excipient Review Pilot Program followed by Q&A.
The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. This Pilot Program will foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients. (Source)
Susan Zuk, MS, Branch Chief, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Ashutosh Rao, Ph.D., Chief, Laboratory of Applied Biochemistry, Supervisory Pharmacologist, SBRBPAS Expert, Office of Biotechnology Products OPQ, CDER, FDA
Robeena M. Aziz, Senior Toxicologist, Office of New Drugs, FDA
IPEC-Americas Members: 89$
IPEC-Americas Non Members: 179$
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