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Novel Excipient Review Pilot Program Overview and Q&A

Description

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)

Contributors

  • Susan Zuk, MS

    Branch Chief, Office of Policy for Pharmaceutical Quality
    OPQ, CDER, FDA
    Susan holds a BS in Chemistry from Syracuse University and a MS in Biotechnology from Johns Hopkins University. During her 19 years with the FDA, she served in the Office of Generic Drugs as a Chemistry Team Leader for many years, specializing in antibiotics. She joined the Office of Policy for Pharmaceutical Quality in 2015 and is currently a Branch Chief in the Division of Regulations, Guidance and Standards. She is the lead for the FDA’s Inactive Ingredient Database (IID). In this role, she is responsible for overseeing IID improvements. Susan has served on many FDA committees and working groups related to product safety and quality. She is currently a member of the FDA’s Center for Drug Evaluation and Research (CDER) Excipient Working Group.

  • Ashutosh Rao, Ph.D.

    Chief, Laboratory of Applied Biochemistry, Supervisory Pharmacologist, SBRBPAS Expert, Office of Biotechnology Products, OPQ, CDER, FDA
    Dr. Rao received his Bachelor’s Degree in Pharmaceutical Sciences at the University of Mumbai and a Ph.D. in molecular pharmacology at the University of Texas M.D. Anderson Cancer Center. Prior to joining the FDA, Dr. Rao completed post-doctoral fellowships at the NIH. During his 15 years at the FDA, he has extensive experience in the regulation of biotechnology products as a Product Quality Team Leader and serves as a subject matter expert on method validation and excipients. He has contributed to multiple FDA guidance documents and policy documents, including for analytical method validation and clinically relevant specifications for impurities. Dr. Rao serves as an FDA liaison to the USP on the polysorbates sub-committee. Additionally, he directs a laboratory regulatory research program that investigates the structure-activity relationship between protein oxidation and biologic drug quality, safety and efficacy.

  • Robeena M. Aziz

    Senior Toxicologist
    Office of New Drugs, FDA
    Bio: Coming soon!

October 27, 2021
Wed 11:00 AM EDT

Duration 2H 0M

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