Latest Federal Register Notices

Guide on Prostate Cancer Drug Development
05/27/2022 Federal Register notice: FDA is making available a final guidance entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.” The document describes FDA’s current recommendations regarding the overall development program and clinical trial designs for developing gonadotropin-releasing hormone analogs to treat advanced prostate cancer. To view the notice, click here.

HHS Withdraws SUNSET Final Rule
05/27/2022 Federal Register notice: Health and Human Services is withdrawing a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) that was published 1/19/2021. The SUNSET final rule was scheduled to take effect 3/22/2021. However, on 3/9 a lawsuit was filed seeking to overturn the final rule, and HHS decided to postpone it during the judicial review. Under the rule, subject to certain exceptions, HHS regulations would expire at the end of (1) two calendar years after the year that the SUNSET rule first became effective, (2) 10 calendar years after the year of the regulation’s promulgation, or (3) 10 calendar years after the last year in which the department “assessed” and, if required, “reviewed” the regulation, whichever was latest. In addition, the final rule contained exemptions for a small set of certain FDA regulations. To view the notice, click here.

Panel to Review Skin Lesion AI Technology
05/26/2022 Federal Register notice: FDA has announced a 7/28-29 meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. On 7/28, the committee will discuss skin lesion analyzer technology and its application in detecting skin cancers in various patient care settings. In recent years, FDA says it has seen an increased interest in developing skin lesion analyzers that employ artificial intelligence and machine learning. On 7/29, the committee will discuss the possible reclassification of approved computer-aided melanoma detection Class 3 devices — MelaFind and Nevisense. To view the notice, click here.

Info Collection on Device Postmarket Surveillance
05/26/2022 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). The collection supports FDA’s authority to require a manufacturer to conduct postmarket surveillance on any device that meets the criteria set forth in the statute. To view the notice, click here.

2 Zydelig Lymphoma Indications Withdrawn
05/25/2022 Federal Register notice: FDA is announcing that it is withdrawing certain indications that received accelerated approval in a Gilead NDA for Zydelig (idelalisib) because the firm failed to demonstrate a clinical benefit in required postmarketing trials. The indications being withdrawn are for relapsed follicular lymphoma and relapsed small lymphocytic lymphoma. To view the notice, click here.