USP Comment to FDA Proposed Novel Excipient Review Program

The United States Pharmacopeia (USP) appreciates the opportunity to provide comments on a potential FDA novel excipient review program. USP is supportive of a novel excipient review program. Establishing new pathways for the development and regulatory review of novel excipients is critical in facilitating innovation for the advancement of new medical products. USP has many existing and developing mechanisms to help support a novel excipient review program. In our comments below, we focus on a novel excipients survey conducted by USP, a discussion on novel excipient naming, USP’s Pending Monograph Process, and the relevance of public standards in this space. USP developed and launched a novel excipients survey in March 2019, the goal of which was to better understand the current drug approval pathway’s impact on novel excipient innovation.

The purpose and objectives of the survey were to identify if any challenges are being experienced by stakeholders related to novel excipients and to better understand views of stakeholders on the current state of innovation in excipients development. The survey results indicated that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients. Based on the survey results, USP is supportive of a novel excipient review program since it provides a pathway for excipients outside of the normal application review process. The full survey results are targeted to be published in the spring of 2020. Download the USP comment here: USP_Comment_to_FDA_Proposed_Novel_Excipient_Review_Program_1580942423

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