> ## 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-151/
- Published: 2017-10-08T12:00:00.000Z
- Updated: 2026-09-14T22:54:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139817

[**Regulatory Review Period Determined for Impella 2.5 System**](https://www.fdaweb.com/regulatory-review-period-determined-for-impella-2-5-system/)  
*Federal Register* notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europe’s Impella 2.5 System. 10/06/2017

[**Regulatory Review Period Determined for Bayer’s Kovaltry**](https://www.fdaweb.com/regulatory-review-period-determined-for-bayers-kovaltry/)  
*Federal Register* notice: FDA determines the regulatory review period for patent extension purposes for Bayer’s Kovaltry (antihemophilic factor (recombinant)). 10/06/2017

[**FDA/Canada Joint Public Meeting on ICH Preparation**](https://www.fdaweb.com/fda-canada-joint-public-meeting-on-ich-preparation/)  
*Federal Register* notice: FDA announces a 10/19 regional public meeting entitled “Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” 10/05/2017

[**Science Advisory Board Meeting Announced**](https://www.fdaweb.com/science-advisory-board-meeting-announced/)  
*Federal Register* notice: FDA announces an 11/6-7 Science Advisory Board to the National Center for Toxicological Research meeting. 10/05/2017

[**Comments Sought on Pregnancy Labeling Requirements**](https://www.fdaweb.com/comments-sought-on-pregnancy-labeling-requirements/)  
*Federal Register* notice: FDA requests comments on an information collection extension for “Content and Format of Labeling for Human Prescription Drugs and Biological Products; Requirements for Pregnancy and Lactation Labeling.” 10/04/2017

[**Patient Engagement Advisory Committee Meeting Amendments**](https://www.fdaweb.com/patient-engagement-advisory-committee-meeting-amendments/)  
*Federal Register* notice: FDA announces amendments to an earlier notice that provided details of a 10/11-12 Patient Engagement Advisory Committee meeting. 10/04/2017

[**Joint FDA Panel to Review Braeburn Pharmaceuticals Drug**](https://www.fdaweb.com/joint-fda-panel-to-review-braeburn-pharmaceuticals-drug/)  
*Federal Register* notice: An FDA advisory committee reviews a Braeburn Pharmaceuticals NDA for buprenorphine subcutaneous injection and its use for treating opioid dependence. 10/03/2017

[**Joint Panel to Mull Opioid Dependence NDA**](https://www.fdaweb.com/joint-panel-to-mull-opioid-dependence-nda/)  
*Federal Register* notice: FDA joint advisory committee meeting reviews Indivior Pharmaceuticals NDA for buprenorphine subcutaneous injection and its use in treating opioid dependence. 10/03/2017

[**Comments Sought on REMS Standards Initiative**](https://www.fdaweb.com/comments-sought-on-rems-standards-initiative/)  
*Federal Register* notice: FDA seeks public input on the design of its REMS Platform Standards Initiative, as well as methods and best practices. 10/03/2017