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# CDER’s Requests for Intarcia Hearing
- URL: https://www.fdaweb.com/cders-requests-for-intarcia-hearing/
- Published: 2023-03-21T12:00:00.000Z
- Updated: 2026-09-14T18:20:53.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5154033

CDER is making several requests if FDA chief scientist **Namandjé Bumpus** grants an Intarcia Therapeutics 2/21 petition seeking a public hearing before the FDA Endocrinologic and Metabolic Drugs Advisory Committee on the Center’s refusal to approve an Intarcia NDA for its ITCA 650 (exenatide in DUROS device). Intarcia submitted its petition [accepting](https://www.fdaweb.com/intarcia-agrees-to-advisory-committee-to-resolve-review-dispute/) Bumpus’ offer to have the committee review the CDER 2021 disapproval of the drug/device combination intended to deliver exenatide, a GLP-1 receptor agonist, as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The CDER [response](https://downloads.regulations.gov/FDA-2023-P-0575-0004/attachment%5F1.pdf?ref=fdaweb.com) says that if Bumpus grants the hearing, the Center would like to have an opportunity to provide input on the statement of issues that would determine the hearing scope. It notes that the Intarcia petition “focuses on only a subset of the issues identified and described in CDER’s 7/29/22 proposed order denying Intarcia’s hearing request.” It says many of the issues identified in the proposed order provide independent grounds for the Center’s proposal to deny approval of the NDA.

CDER also asks that any hearing be scheduled with enough time to choose ad hoc members of the advisory committee so the committee will have one or more members with sufficient expertise to evaluate a combination product and one or more members with sufficient expertise in the specific issues to be addressed in the hearing.

Finally, CDER says it could not fully prepare for a hearing until the notice of alternative form of hearing stating the issues to be considered is published. Thus, it says, it asks that any hearing timeline account for adequate time to schedule and hold the meeting, develop the statement of issues, and select ad hoc committee members, as well as adequate time for both parties to prepare for a hearing once the statement of issues has been published.