FDA ANNOUNCES DOCKET FOR NOVEL EXCIPIENT REVIEW PROGRAM!!!!
FDA (the Agency or we) has announced the establishment of a docket to obtain information and comments that will assist the Agency in determining whether it should establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. The Agency hopes to obtain information and comments on several aspects of such a program before deciding whether to develop it.
IPEC-Americas and the IQ Consortium has been working with FDA for some time to try to get this type of program established for novel excipient safety reviews. This program is needed to help drug developers and excipient companies innovate and resolve the formulation problems that currently exist with many of the newer APIs that are very insoluble or where new dosage forms are needed. It will be important that all companies submit supportive comments to the docket if they feel that they would benefit from using novel excipients with a better regulatory pathway to reduce risk. The deadline to submit comments in February 3, 2020. Get your comments submitted. This is a very important program that we need FDA to establish!
https://www.federalregister.gov/documents/2019/12/05/2019-26266/novel-excipient-review-program-proposal-request-for-information-and-comments FDA Novel Excipient Review Program Proposal; Request for Information and Comments; Notice; request for information and comments