Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate drug delivery, promote solubility, improve taste and, in general, allow active pharmaceutical ingredients to be transformed into useable dosage forms. For over 30 years, FDA has published the Inactive Ingredient Database (IID), a publicly available list of the excipients used in FDA approved drug products, as a tool for drug development. Over the years, FDA has made small gradual improvements to the IID in response to requests from industry. But the format and information provided in the IID remained basically the same.
In 2019, FDA published a draft guidance for industry on use of the IID. This guidance not only provided advice to industry on how the IID can best be used to develop drug products and prepare applications, but also identified plans for important future IID enhancements that will be made by October 2020. In 2020, the IID will change in some significant and positive ways as FDA fulfills the commitments made to industry under the 2017 reauthorization of the Generic Drug User Fee Amendments (GDUFA II). What will the IID look like when these commitments are fulfilled? How will these changes impact drug applications, especially with respect to qualification of the excipients used in those drug products? What are the advantages of the IID’s new structure? Are there still unaddressed needs?
In this presentation, FDA will identify all the changes that have occurred in preparation for fulfilling our GDUFA II commitments for the IID and changes yet to come in 2020. FDA will provide its vision for the IID as an essential tool for drug development.
- How FDA plans to ensure the IID remains accurate, current, and searchable
- How the changes will impact the formulator and their selection of excipients
- FDA process and timing for updating the IID with inclusion of MDE
- Evaluation of potential changes and how will current potency values be linked to new MDEs
- Process transparency for industry to evaluate integrity of data and impact of changes
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.