> ## 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-168/
- Published: 2018-02-25T12:00:00.000Z
- Updated: 2026-09-14T23:25:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140847

[**24 ANDA Approvals Withdrawn**](https://www.fdaweb.com/24-anda-approvals-withdrawn/)  
*Federal Register* notice: FDA withdraws approval of 24 ANDAs from multiple applicants because the products are no longer marketed. 02/23/2018

[**Regulatory Review Period Determined for Zydelig**](https://www.fdaweb.com/regulatory-review-period-determined-for-zydelig/)  
*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for ICOS Corp.'s Zydelig (idelalisib) is 2,247 days. 02/23/2018

[**FDA Panel Meeting to Review Device Reclassifications**](https://www.fdaweb.com/fda-panel-meeting-to-review-device-reclassifications/)  
*Federal Register* notice: FDA announcesa 3/21-22 joint meeting of its Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee to review two device reclassifications. 02/22/2018

[**Medical Device Labeling Information Collection Extension**](https://www.fdaweb.com/medical-device-labeling-information-collection-extension/)  
*Federal Register* notice: FDA seeks comments on an information collection exetension for “Medical Device Labeling Regulations — 21 CFR parts 800, 801, and 809” (OMB Control Number 0910-0485). 02/22/2018

[**Panel to Review Cannabidiol NDA**](https://www.fdaweb.com/panel-to-review-cannabidiol-nda/)  
*Federal Register* notice: FDA announces a 4/19 Peripheral and Central Nervous System Drugs Advisory Committee meeting. 02/22/2018

[**Final Rule on Device Trials Conducted Outside U.S.**](https://www.fdaweb.com/final-rule-on-device-trials-conducted-outside-u-s/)  
*Federal Register* final rule: FDA amends its regulations on data acceptance from clinical investigations for medical devices conducted outside the U.S. to support a device submission to require that such studies be conducted in accordance with good clinical practice. 02/21/2018

[**Regulatory Review Period Determined for Darzalex**](https://www.fdaweb.com/regulatory-review-period-determined-for-darzalex/)  
*Federal Register* notice: FDA determines for patent extension purposes that the regulatory review period for Genmab’s Darzalex (daratumumab) is 1,939 days. 02/20/2018

[**Regulatory Review Period Determined for Portrazza**](https://www.fdaweb.com/regulatory-review-period-determined-for-portrazza/)  
*Federal Register* notice: FDA determines for patent extension purposes that the regulatory review period for Eli Lilly’s Portrazza (necitumumab) is 2,533 days. 02/20/2018

[**Laboratory Reorganization Under FDA Program Alignment**](https://www.fdaweb.com/laboratory-reorganization-under-fda-program-alignment/)  
*Federal Register* notice: FDA announces that its Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, and Office of Regulatory Science have been restructured 6/2016 under its Program Alignment Initiative. 02/20/2018