> ## 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-164/
- Published: 2018-01-28T12:00:00.000Z
- Updated: 2026-09-14T23:17:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140622

[**Regulatory Review Period Determined for Vraylar**](https://www.fdaweb.com/regulatory-review-period-determined-for-vraylar/)  
*Federal Register* notice: FDA determines for patent extension purposes the regulatory review period for Forest Labs Vraylar (cariprazine) to be 3,742 days. 01/26/2018

[**Regulatory Review Period Determined for Varubi**](https://www.fdaweb.com/regulatory-review-period-determined-for-varubi/)  
*Federal Register* notice: FDA determines for patent extension purposes the regulatory review period for OPKO Health’s Varubi (rolapitant) to be 3,070 days. 01/26/2018

[**Pharma Science Panel Renewed**](https://www.fdaweb.com/pharma-science-panel-renewed/)  
*Federal Register* notice: FDA announces that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee has been renewed for an additional two years beyond the charter expiration date. 01/25/2018

[**Rule Issued on Biologic Inspection Timing, Requirements**](https://www.fdaweb.com/rule-issued-on-biologic-inspection-timing-requirements/)  
*Federal Register* direct final rule: FDA amends its general biologics regulations relating to time of inspection requirements and to remove duties of inspector requirements. 01/25/2018

[**Comments Extended on 510(k)/CLIA App Studies**](https://www.fdaweb.com/comments-extended-on-510-k-clia-app-studies/)  
*Federal Register* notice: FDA extends the comment period on a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” 01/25/2018

[**Joint Panel to Meet on Drug Study for Treating Achondroplasia**](https://www.fdaweb.com/joint-panel-to-meet-on-drug-study-for-treating-achondroplasia/)  
*Federal Register* notice: FDA announces a 3/22 joint Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting. 01/23/2018

[**Timetable for e-Study Data Submissions**](https://www.fdaweb.com/timetable-for-e-study-data-submissions/)  
*Federal Register* notice: FDA announces a timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDAs, BLAs and certain INDs. 01/23/2018

[**Comments Extended on ‘Least Burdensome’ Device Guide**](https://www.fdaweb.com/comments-extended-on-least-burdensome-device-guide/)  
*Federal Register* notice: FDA extends the comment period on a draft guidance entitled “The Least Burdensome Provisions: Concept and Principles.” 01/23/2018