> ## 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-155/
- Published: 2017-11-05T12:00:00.000Z
- Updated: 2026-09-14T23:00:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140061

[**Draft Guide on ANDA Pre-submission Facility Info**](http://fdaweb.com/login.php?sa=v&aid=D5140053&cate=FR&stid=%241%24Ks2.LC0.%24042kVsJAJrhfzw9KDPuro0&ref=fdaweb.com)  
*Federal Register* notice: FDA makesavailable a revised draft guidance entitled “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).” 11/06/2017

[**Bayer’s Revex Not Withdrawn Due to Safety/Effectiveness**](https://www.fdaweb.com/bayers-revex-not-withdrawn-due-to-safety-effectiveness/)  
*Federal Register* notice: FDA determines that Bayer’s Revex (nalmefene hydrochloride injection), which is indicated for reversing an opioid overdose, was not withdrawn due to safety or effectiveness issues. 11/03/2017

[**Draft Guide on Controlled Correspondence for Generics**](https://www.fdaweb.com/draft-guide-on-controlled-correspondence-for-generics/)  
*Federal Register* notice: FDA makes available a draft guidance on “Controlled Correspondence Related to Generic Drug Development.” 11/03/2017

[**FDA Renews Patient Engagement Advisory Committee for 2 Years**](https://www.fdaweb.com/fda-renews-patient-engagement-advisory-committee-for-2-years/)  
*Federal Register* notice: FDA announces the renewal of the Patient Engagement Advisory Committee for an additional two years. 11/02/2017

[**Comments Sought on Radiopharmaceuticals Info Collection**](https://www.fdaweb.com/comments-sought-on-radiopharmaceuticals-info-collection/)  
*Federal Register* notice: FDA seeks comments on an information collection extension for “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — OMB Control Number 0910-0409.” 11/02/2017

[**Nominations Sought for Pediatric Advisory Committee Rep**](https://www.fdaweb.com/nominations-sought-for-pediatric-advisory-committee-rep/)  
*Federal Register* notice: FDA seeks nominations for a nonvoting industry representative to serve on its Pediatric Advisory Committee. 11/02/2017

[**Public Meeting on FDA Hiring and Retention**](https://www.fdaweb.com/public-meeting-on-fda-hiring-and-retention/)  
*Federal Register* notice: FDA announces an 11/30 public meeting on “Assessment of FDA Hiring and Retention” that will share high-level findings from a recently completed examination of the agency’s hiring process conducted by an independent contractor. 11/02/2017

[**Draft ICH Guidance on Drug Trial Statistical Principles**](https://www.fdaweb.com/draft-ich-guidance-on-drug-trial-statistical-principles/)  
*Federal Register* notice: FDA makes available an International Council for Harmonization draft guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” 11/01/2017

[**Workshop on Opioid Packaging/Storgage/Disposal**](https://www.fdaweb.com/workshop-on-opioid-packaging-storgage-disposal/)  
*Federal Register* notice: FDA announces a 12/11-12 public workshop on “Packaging, Storage, and Disposal Options To Enhance Opioid Safety — Exploring the Path Forward.” 11/01/2017