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. Join us for an overview of the pilot followed by Q&A. (Source)
Audience
Roles
> Research & Development
> Quality
> Regulatory
> Formulations
Industry Segments
> Pharmaceutical - Originator Drugs
> Biologics - Biotech Drugs (Originators)
> Biologics - Biosimilars (Follow on Biologics)
> Medical Device / Combination Products
> Consumer Goods (Medical Products)
Presenter(s)
Susan Zuk, MS
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.