> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-79/
- Published: 2022-05-08T12:00:00.000Z
- Updated: 2026-09-14T17:43:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151772

**Diabetes Device Feasibility Studies Guidance**  
05/06/2022 *Federal Register* notice: FDA has made available a final guidance entitled “Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus.” The document’s scope applies to devices such as neurostimulators, and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines, or manipulate the sympathetic nervous system. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-06/pdf/2022-09738.pdf?ref=fdaweb.com).

**Guide on Radiolabeled Mass Balance Studies**  
05/05/2022 *Federal Register* notice: FDA has made available a draft guidance entitled “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.” The document describes agency recommendations on deciding whether and when to conduct such studies, study designs, and reporting results. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-05/pdf/2022-09608.pdf?ref=fdaweb.com).

**Anesthetic/Analgesic Drugs Panel Renewal**  
05/04/2022 *Federal Register* notice: FDA has announced its renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/1/2024\. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-09610.pdf?ref=fdaweb.com).

**Marqibo Accelerated Approval Withdrawn**  
05/02/2022 *Federal Register* notice: FDA is withdrawing the accelerated approval of Acrotech Biopharma’s NDA for Marqibo (vincristine sulfate liposome injection), indicated for treating certain adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia. The company requested the withdrawal due to agency concerns that a postmarketing trial required to verify clinical benefit had not been completed, and patient recruitment to fulfill the requirement appeared to be significantly challenging due to the treatment options that are currently available. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-02/pdf/2022-09235.pdf?ref=fdaweb.com).

**Regeneron Awarded Priority Review Voucher**  
05/02/2022 *Federal Register* notice: FDA has issued Regeneron Pharmaceuticals a priority review voucher under its material threat medical countermeasure product program. The voucher was awarded after FDA determined that Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), indicated for treating infections caused by Zaire ebolavirus, met the program’s criteria. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-02/pdf/2022-09315.pdf?ref=fdaweb.com).