> ## 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-188/
- Published: 2018-07-29T12:00:00.000Z
- Updated: 2026-09-15T00:22:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141996

[**Draft Guide on Rare Diseases with Substrate Deposition**](https://www.fdaweb.com/draft-guide-on-rare-diseases-with-substrate-deposition/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” 07/27/2018

[**Guide on Certain Pediatric Orphan Designations**](https://www.fdaweb.com/guide-on-certain-pediatric-orphan-designations/)  
*Federal Register* notice: FDA makes available a final guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” 07/27/2018

[**FY 2019 Generic Drug User Fees Set**](https://www.fdaweb.com/fy-2019-generic-drug-user-fees-set/)  
*Federal Register* notice: FDA announces the fiscal year 2019 rates for generic drug program areas. 07/27/2018

[**Guide on Peripheral Vascular Atherectomy Devices**](https://www.fdaweb.com/guide-on-peripheral-vascular-atherectomy-devices-2/)  
*Federal Register* notice: FDA releases a draft guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification \[510(k)\] Submissions.” 07/27/2018

[**Metaxalone not Withdrawn Due to Safety/Effectiveness: FDA**](https://www.fdaweb.com/metaxalone-not-withdrawn-due-to-safety-effectiveness-fda/)  
*Federal Register* notice: FDA determines that metaxalone tablets, 640 mg were not withdrawn from sale for reasons of safety or effectiveness. 07/27/2018

[**Info Collection Extension for Product Interruption Notices**](https://www.fdaweb.com/info-collection-extension-for-product-interruption-notices/)  
*Federal Register* notice: FDA submits to OMB an information collection extension for “Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products — 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82.” 07/26/2018

[**Guide on Certain Drug Quality Assessments**](https://www.fdaweb.com/guide-on-certain-drug-quality-assessments/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.” 07/25/2018

[**FDA Hearing on Improving Biosimilar Marketplace**](https://www.fdaweb.com/fda-hearing-on-improving-biosimilar-marketplace/)  
*Federal Register* notice: FDA announces a 9/4 public hearing on its approach to enhancing competition and innovation in the biological products marketplace. 07/25/2018

[**Pharmacy Compounding Advisory Committee Meeting 9/12**](https://www.fdaweb.com/pharmacy-compounding-advisory-committee-meeting-9-12/)  
*Federal Register* notice: FDA announces a 9/12 Pharmacy Compounding Advisory Committee meeting. 07/24/2018

[**Workshop on Otic and Vestibular Toxicity**](https://www.fdaweb.com/workshop-on-otic-and-vestibular-toxicity/)  
*Federal Register* notice: FDA announces an 8/21 public workshop entitled “Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.” 07/24/2018

[**Draft Guide on Inborn Errors of Metabolism**](https://www.fdaweb.com/draft-guide-on-inborn-errors-of-metabolism/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” 07/24/2018