> ## 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-185/
- Published: 2018-06-24T12:00:00.000Z
- Updated: 2026-09-15T00:15:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141766

[**Draft Guide on Major Depressive Disorder Drugs**](https://www.fdaweb.com/draft-guide-on-major-depressive-disorder-drugs/)  
*Federal Register* notice: FDA makes available a draft guidance for industry entitled “Major Depressive Disorder: Developing Drugs for Treatment.” 06/22/2018

[**Next Gen Sequencing Tumor Profiling Test in Class 2**](https://www.fdaweb.com/next-gen-sequencing-tumor-profiling-test-in-class-2/)  
*Federal Register* notice: FDA classifies the next-generation sequencing-based tumor profiling test into Class 2 (special controls). 06/22/2018

[**Draft Guidance on Drug User Fee Waivers**](https://www.fdaweb.com/draft-guidance-on-drug-user-fee-waivers/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” 06/21/2018

[**Antimicrobial Drugs Panel to Review 2 NDAs**](https://www.fdaweb.com/antimicrobial-drugs-panel-to-review-2-ndas/)  
*Federal Register* notice: FDA announces an 8/8 Antimicrobial Drugs Advisory Committee meeting two review two Paratek Pharmaceuticals NDAs. 06/21/2018

[**Info Collection Extension for Adverse Event Reporting** ](https://www.fdaweb.com/info-collection-extension-for-adverse-event-reporting/)*Federal Register* notice: FDA seeks comments on an information collection extension for its “Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” 06/20/2018

[**FDA Withdraws Approval of 5 NDAs**](https://www.fdaweb.com/fda-withdraws-approval-of-5-ndas/)  
*Federal Register* notice: FDA has withdrawn the approval of five NDAs from multiple applicants. 06/20/2018

[**Several Information Collections Approved by OMB**](https://www.fdaweb.com/several-information-collections-approved-by-omb-2/)  
*Federal Register* notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget. 06/19/2018

[**Draft Guide on Nonclinical Anticancer Trials**](https://www.fdaweb.com/draft-guide-on-nonclinical-anticancer-trials/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers.” 06/19/2018