> ## 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-191/
- Published: 2018-08-19T12:00:00.000Z
- Updated: 2026-09-15T00:26:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142152

[**Quality Metrics Proposal Period Extended**](https://www.fdaweb.com/quality-metrics-proposal-period-extended/)  
*Federal Register* notice: FDA extends the proposal period for its “Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff” to allow interested persons additional time to submit a proposal. 08/17/2018

[**Info Collection Extension for Generic Development Guide**](https://www.fdaweb.com/info-collection-extension-for-generic-development-guide/)  
*Federal Register* notice: FDA submits to OMB an information collection extension entitled “Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.” 08/17/2018

[**Device Alternative Malfunction Reporting**](https://www.fdaweb.com/device-alternative-malfunction-reporting/)  
*Federal Register* notice: FDA grants an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. 08/17/2018

[**Proposal to Classify Device Accessories into Class 1**](https://www.fdaweb.com/proposal-to-classify-device-accessories-into-class-1/)  
*Federal Register* notice: FDA identifies a list of device accessories for which it believes general controls are sufficient to provide reasonable assurance of safety and effectiveness. 08/17/2018

[**Workshop on Microbiome-Based Products**](https://www.fdaweb.com/workshop-on-microbiome-based-products/)  
*Federal Register* notice: FDA announces a 9/17 workshop entitled “Science and Regulation of Live Microbiome-Based Products Used To Prevent, Treat, or Cure Diseases in Humans.” 08/17/2018

[**Comments Sought on IND Surveys Under User Fee Program**](https://www.fdaweb.com/comments-sought-on-ind-surveys-under-user-fee-program/)  
*Federal Register* notice: FDA seeks comments on a new information collection entitled “Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI).” 08/16/2018

[**Priority Preview Voucher Granted to Ultragenyx**](https://www.fdaweb.com/priority-preview-voucher-granted-to-ultragenyx/)  
*Federal Register* notice: FDA issued a priority review voucher to Ultragenyx Pharmaceutical for its approved rare pediatric disease product application. 08/15/2018

[**Joint Advisory Panel to Discuss Modernizing Drug Assessments**](https://www.fdaweb.com/joint-advisory-panel-to-discuss-modernizing-drug-assessments/)  
*Federal Register* notice: FDA announces a 9/20 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting that will discuss modernizing drug application assessments. 08/15/2018

[**FDA Withdraws 20 Unmarketed ANDAs** ](https://www.fdaweb.com/fda-withdraws-20-unmarketed-andas/)*Federal Register* notice: FDA withdraws the approval of 20 ANDAs from multiple applicants. 08/14/2018