> ## 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-60/
- Published: 2021-10-24T12:00:00.000Z
- Updated: 2026-09-14T17:20:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150434

**FDA Withdraws Approval for 216 ANDAs**  
10/22/2021 *Federal Register* notice: FDA has withdrawn the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports to the agency. Previousy, FDA published a notice offering an opportunity for a hearing on proposal to withdraw approval, and the holders of the 216 applications did not respond. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-10-22/pdf/2021-23075.pdf?ref=fdaweb.com).

**Guide on Submitting Real-world Data**  
10/22/2021 *Federal Register* notice: FDA has made available a draft guidance entitled *Data Standards for Drug and Biological Product Submissions Containing Real-World Data*. The document provides recommendations to sponsors when submitting study data derived from real-world data sources in applicable regulatory submissions using standards specified in the Data Standards Catalog. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-10-22/pdf/2021-23081.pdf?ref=fdaweb.com).

**Regulatory Review Determined for Orion’s Nubeqa**  
10/21/2021 *Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Orion Corp.’s Nubeqa (darolutamide), indicated for treating patients with non-metastatic castration-resistant prostate cancer. The regulatory review period is 2,576 days, which includes 2,420 days that occurred during the testing phase and 156 days during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-23074.pdf?ref=fdaweb.com).

**OTC Hearing Aids Proposed Rule**  
10/20/2021 *Federal Register* proposed rule: FDA is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for such devices. Specifically, it seeks to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from federal preemption that would become obsolete as a result of changes to the hearing aid requirements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-10-20/pdf/2021-22473.pdf?ref=fdaweb.com).