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MAY 13
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FDA Speakers

Matt Dionne, PharmD, MBA
Compliance Officer

Matt Dionne is a pharmacist serving in the United States Public Health Service and Compliance Officer in the Office of Manufacturing Quality (OMQ) in the FDA’s Center for Drug Evaluation and Research (CDER). He received a Pharm.D. from the University of Rhode Island in 2001 and Master of Business Administration from Colorado State University in 2012. He joined FDA in 2006 and has experience in regulatory oversight and enforcement for a wide range of drug products from complex sterile injectables to topical over-the-counter products. He also led many of the CDER OMQ excipient initiatives related to the 2022-2023 international diethylene glycol and ethylene glycol poisoning.

Presentation Title: Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Description: This presentation will provide an update on the potential public health hazard of glycerin and other high-risk drug components contaminated with diethylene glycol (DEG) or ethylene glycol (EG).  The update will include an overview of current DEG/EG outbreaks overseas and FDA’s role in this issue (ex. guidance and recent compliance actions).

Amanda Jones, Ph.D.
Lead Pharmacologist
Dr. Amanda Jones is a Lead Pharmacologist in the Division of Bioequivalence I (DBI), in the Office of Bioequivalence (OB), Office of Generic Drugs (OGD), within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).  In this role, Dr. Jones expertly guides a team of pharmacologists dedicated to the assessment of in vivo and in vitro bioequivalence data for a diverse range of generic drug products supporting Abbreviated New Drug Applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act.  She has been an integral member on various committees and working groups within CDER, including the Inactive Ingredient Database (IID) Transfer Team.  Prior to joining the FDA in 2014, Dr. Jones was the Toxicologist Leader at GTx, Inc. (Memphis, TN) where she coordinated and monitored non-clinical safety pharmacology and toxicology studies and supervised phase I clinical trials.  Dr. Jones received her Ph.D. in Pharmaceutics from The Ohio State University. 

Presentation Title: FDA’s Inactive Ingredient Database (IID) Update

Description: Since 2003, FDA has published the Inactive Ingredient Database (IID), a publicly available list of excipients present in FDA-approved drug products, which is an essential tool in evaluating excipient safety during drug development.  FDA continually updates the IID and posts quarterly notices of updates made, including each change made and, for each change, the information replaced.  Notably, these enhancements have included populating the IID with accurate maximum daily exposure information for each route of administration for which data is available, with increasingly more data with each quarterly update.  This presentation will provide an overview of the IID and highlight the continued efforts made by FDA to enhance the database.