> ## 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-78/
- Published: 2022-05-01T12:00:00.000Z
- Updated: 2026-09-14T17:42:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151624

**Guide on Bioavailability Studies for Drug Submissions**  
04/29/2022 *Federal Register* notice: FDA is making available a final guidance entitled *Bioavailability Studies Submitted in* *NDAs or INDs — General Considerations*. The document provides recommendations to sponsors planning to include bioavailability information in INDs, NDAs and supplemental NDAs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-15/pdf/2022-08114.pdf?ref=fdaweb.com).

**Draft Guide on Celiac Disease Drugs**  
04/28/2022 *Federal Register* notice: FDA is making available a draft guidance entitled *Celiac Disease: Developing Drugs for* *Adjunctive Treatment to a Gluten-Free Diet*. The document addresses agency recommendations regarding clinical trials for such drugs. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-08116.pdf?ref=fdaweb.com).

**Guide on ANDA Waivers for pH Adjusters**  
04/28/2022 *Federal Register* notice: FDA is making available a draft guidance entitled *Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use*. The document is intended to assist ANDA applicants seeking approval of a drug that is qualitatively different or quantitatively different from a reference listed drug with respect to the pH adjuster. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-14/pdf/2022-08012.pdf?ref=fdaweb.com).

**Draft Guide on Trial Diversity Plans**  
04/28/2022 *Federal Register* notice: FDA has made available a draft guidance entitled *Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials*. The document offers recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in compliant clinical trials. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-14/pdf/2022-07978.pdf?ref=fdaweb.com).

**Gene Therapies Panel Reviews 2 bluebird BLAs**  
04/27/2022 *Federal Register* notice: FDA has announced a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss two bluebird bio BLAs: (**1**) a BLA for elivaldogene autotemcel for treating patients younger than 18 years of age with early cerebral adrenoleukodystrophy who do not have an available and willing human leukocyte antigen-matched sibling hematopoietic stem cell donor; and (**2**) a BLA for betibeglogene autotemcel for treating patients with β-thalassemia who require regular red blood cell transfusions. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-08022.pdf?ref=fdaweb.com).

**Device Guides on Denture Base Screws**  
04/27/2022 *Federal Register* notice: FDA has made available two final device-specific guidance documents for the Safety and Performance Based Pathway. One is on *Denture Base Resins — Performance Criteria for Safety and Performance Based Pathway*, and the other is on *Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway*. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-04-13/pdf/2022-07934.pdf?ref=fdaweb.com).