> ## 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-211/
- Published: 2019-02-18T12:00:00.000Z
- Updated: 2026-09-15T01:05:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143414

[**Comments Reopened on Real World Evidence Program**](https://www.fdaweb.com/comments-reopened-on-real-world-evidence-program/)  
*Federal Register* notice: FDA reopens the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” 02/15/2019

[**Panel to Discuss Breast Implant Benefit/Risk**](https://www.fdaweb.com/panel-to-discuss-breast-implant-benefit-risk/)  
*Federal Register* notice: FDA announces a 3/25-26 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting that will discuss benefits and risks of breast implants indicated for breast augmentation and reconstruction. 02/15/2019

[**Established Conditions Pilot Program for Drugs**](https://www.fdaweb.com/established-conditions-pilot-program-for-drugs/)  
*Federal Register* notice: CDER provides an opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program. 02/15/2019

[**Info Collection Extension on Export Notifications/Recordkeeping**](https://www.fdaweb.com/info-collection-extension-on-export-notifications-recordkeeping/)  
*Federal Register* notice: FDA seeks comments on an information collection extension for “Exports: Notification and Recordkeeping Requirements — 21 CFR 1.101.” 02/15/2019

[**Lotrimin Not Withdrawn Over Safety/Efficacy: FDA**](https://www.fdaweb.com/lotrimin-not-withdrawn-over-safety-efficacy-fda/)  
*Federal Register* notice: FDA determines that Schering-Plough Healthcare Products’ Lotrimin (clotrimazole) topical solution, 1%, was not withdrawn from sale for safety or effectiveness reasons. 02/14/2019

[**Guide on CDER Quality Consensus Standards Program**](https://www.fdaweb.com/guide-on-cder-quality-consensus-standards-program/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” 02/14/2019

[**Takeda’s Omontys Withdrawm Due to Adverse Events**](https://www.fdaweb.com/takedas-omontys-withdrawm-due-to-adverse-events/)  
*Federal Register* notice: FDA announces the withdrawal of a Takeda Pharmaceuticals NDA for Omontys (peginesatide) injection, indicated for treating anemia due to chronic kidney disease in adult patients on dialysis. 02/14/2019

[**Regulatory Review Determined for Anacor Pharma’s Eucrisa**](https://www.fdaweb.com/regulatory-review-determined-for-anacor-pharmas-eucrisa/)  
*Federal Register* notice: FDA determines the regulatory review period for Anacor Pharmaceuticals’ Eucrisa (crisaborole), indicated for topical treatment of mild to moderate atopic dermatitis. 02/13/2019