June Page, PharmD
Senior Regulatory Officer
OCQC | CDER | FDA
CDR June Page is a Senior Regulatory Officer at FDA within CDER’s Office of Compounding Quality and Compliance, Division of Compounding I. She serves as the Data Integrity Subject Matter Expert within OCQC. CDR Page has served on several instructor-led and web-based trainings for Outsourcing Facilities and is the lead for the Data Integrity Training course. Prior to joining CDER in 2020, CDR Page served as a Drug Specialist with FDA’s Office of Regulatory Affairs, Office of Pharmaceutical Quality Operations. Before beginning her tenure at FDA, she worked as a pharmacist with both Indian Health Service and the Center for Medicare & Medicaid. CDR Page is board certified in Compounded Sterile Preparations Pharmacy. She received her Doctor of Pharmacy degree from South University and her MPH from George Washington University.
Presentation Title: FDA’s Expectations for Data Integrity
Amanda Jones, Ph.D.
OGD | CDER | FDA
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.