USA – Excipients group seeks GDUFA III participation

Increasing the timely, safe, and cost-effective availability of generic drugs requires that excipient issues be addressed as an integral part of the process, said Priscilla Zawislak, Immediate Past-Chair of International Pharmaceutical Excipients Council (IPEC)-Americas.

Zawislak, speaking at the 21 June 2020 public hearing kicking off the reauthorization process for the third Generic Drug Fees User Amendments (GDUFA III), said that excipient manufacturers are also asking for improvements in communication with FDA on excipient issues, and for formal inclusion of IPEC-Americas in the ongoing GDUFA discussions.
“Excipient issues need to be incorporated into the GDUFA agreements in a way that will benefit FDA, industry and the patient. We request the opportunity to help ensure that the data in the [Inactive Ingreident Database] are complete, consistent, accurate and maintained as such throughout the data lifecycle,” said Zawislak. (RELATED: FDA kicks off GDUFA III reauthorization process, Regulatory Focus, 21 July 2020)