> ## 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-55/
- Published: 2021-09-19T12:00:00.000Z
- Updated: 2026-09-14T17:15:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150178

**Q & A Guide on Biosimilar Development**  
9/17/2021 *Federal Register* notice: FDA has made available a [final guidance ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act-guidance-industry?ref=fdaweb.com)entitled *Questions and Answers on Biosimilar Development and the BPCI Act*. The document is intended to inform prospective applicants about the development of proposed biosimilars and proposed interchangeable biosimilars. It also describes FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009\. The guidance revises a 2018 document under the same title. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-20255.pdf?ref=fdaweb.com).

**Revised Guide on Ferric Oxyhydroxide ANDAs**  
9/16/2021 *Federal Register* notice: FDA has made available a revised draft guidance for industry entitled *Draft Guidance for Ferric Oxyhydroxide*. The document provides product-specific recommendations on the design of bioequivalence studies to support ANDAs for ferric oxyhydroxide oral tablets and intravenous injectable products. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-20064.pdf?ref=fdaweb.com).

**Info Collection on Biosimilar User Fees**  
9/16/2021 *Federal Register* notice: FDA is seeking comments on an information collection revision entitled “Biosimilars User Fee Program” (OMB Control Number 0910-0718). For efficiency purposes, the agency is consolidating a related information collection on current user fee commitment goals as set forth in the document “BsUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022.” To view the notice, click [here](https://public-inspection.federalregister.gov/2021-20060.pdf?ref=fdaweb.com).