> ## 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-186/
- Published: 2018-07-08T12:00:00.000Z
- Updated: 2026-09-15T00:17:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141824

[**Draft Guide on Drug Indications Labeling**](http://fdaweb.com/login.php?sa=v&aid=D5141809&cate=FR&stid=%241%24wA5.3X..%24lD56oD5.hi945ryJg2kn.1&ref=fdaweb.com)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” 07/09/2018

[**Comments Sought on Biosimilar Info Collection**](http://fdaweb.com/login.php?sa=v&aid=D5141810&cate=FR&stid=%241%24wA5.3X..%24lD56oD5.hi945ryJg2kn.1&ref=fdaweb.com)  
*Federal Register* notice: FDA seeks comments on a information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications.” 07/09/2018

[**Panel to Review Insmed Lung Disease Drug**](http://fdaweb.com/login.php?sa=v&aid=D5141811&cate=FR&stid=%241%24wA5.3X..%24lD56oD5.hi945ryJg2kn.1&ref=fdaweb.com)  
*Federal Register* notice: FDA announces an 8/7 Antimicrobial Drugs Advisory Committee meeting. 07/09/2018

[**Guide on Biosimilar User Fee Program**](https://www.fdaweb.com/guide-on-biosimilar-user-fee-program/)  
*Federal Register* notice: FDA makes available a final guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” 06/29/2018

[**Draft Guide on Oncology Therapeutic Radiopharmaceuticals**](https://www.fdaweb.com/draft-guide-on-oncology-therapeutic-radiopharmaceuticals/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” 06/29/2018

[**Workshop on Non-traditional Therapies for Bacterial Infections** ](https://www.fdaweb.com/workshop-on-non-traditional-therapies-for-bacterial-infections/)*Federal Register* notice: FDA announces an 8/22 public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections.” 06/28/2018

[**Comments Sought on Biosimilar Fee Program Info Collection**](https://www.fdaweb.com/comments-sought-on-biosimilar-fee-program-info-collection/)  
*Federal Register* notice: FDA seeks comments on an information collection extension for “Biosimilars User Fee Program.” 06/28/2018

[**Hearing on FDA’s Predictive Toxicology Roadmap**](https://www.fdaweb.com/hearing-on-fdas-predictive-toxicology-roadmap/)  
*Federal Register* notice: FDA announces a 9/12 public hearing to solicit comments on its Predictive Toxicology Roadmap. 06/28/2018

[**Info Collection Extension on State Enforcement Notifications**](https://www.fdaweb.com/info-collection-extension-on-state-enforcement-notifications/)  
*Federal Register* notice: FDA files for OMB approval a proposed information extension for “State Enforcement Notifications.” 06/27/2018

[**Panel to Review Malaria Drug NDA**](https://www.fdaweb.com/panel-to-review-malaria-drug-nda/)  
*Federal Register* notice: FDA announces a 7/26 Antimicrobial Drugs Advisory Committee meeting that will review a 60 Degrees Pharmaceuticals NDA for a malaria drug. 06/26/2018