> ## 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-44/
- Published: 2021-06-20T12:00:00.000Z
- Updated: 2026-09-14T17:04:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149584

**Guide on Premenopausal Women with Breast Cancer**  
6/17/2021 *Federal Register* notice: FDA has made available a final guidance entitled *Premenopausal Women with Breast Cancer: Developing Drugs for Treatment*. The document provides recommendations about including premenopausal women in breast cancer clinical trials. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-12974.pdf?ref=fdaweb.com).

**Progressive Multifocal Leukoencephalopathy Trials Workshop**  
6/17/2021 *Federal Register* notice: FDA has announced a 9/21 public workshop entitled “Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs.” The workshop is intended to discuss the challenges and clinical trial design considerations for developing therapeutic products for treating progressive multifocal leukoencephalopathy. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-12967.pdf?ref=fdaweb.com).

**Notice Correction on ANDA Approval Withdrawal**  
6/15/2021 *Federal Register* notice: FDA is correcting a 5/12 notice about the withdrawal of approval of 12 ANDAs from multiple applicants. That notice indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the notice was published with an incorrect application number for the product. This notice corrects that error. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-06-15/pdf/2021-12557.pdf?ref=fdaweb.com).

**Panel Meeting to Review TransMedics PMA**  
06/14/2021 *Federal Register* notice: FDA has announced a 7/14 meeting of its Medical Devices Advisory Committee’s Gastroenterology and Urology Devices Panel. The committee is scheduled to discuss, make recommendations, and vote on information on a TransMedics PMA for the Organ Care Liver System, indicated for the resuscitation, preservation, and assessment of liver allografts from donors after brain death or liver allografts from donors after circulatory death. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-06-11/pdf/2021-12266.pdf?ref=fdaweb.com).

**Notice Corrected on Bravecto Review Period**  
06/14/2021 *Federal Register* notice correction: FDA is correcting a 2/12/2018 *Federal Register* notice to revise the regulatory review period for Merck’s Bravecto (fluralaner), indicated for flea and tick prevention in dogs and cats. The notice is corrected as follows: FDA has determined that the applicable regulatory review period for Bravecto is 1,054 days. Of this time, 1,016 days occurred during the testing phase and 38 days occurred during the approval phase. Based on the correction, it appears Bravecto could be eligible for an additional 37 days of patent protection. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-06-11/pdf/2021-12284.pdf?ref=fdaweb.com).