> ## 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-187/
- Published: 2018-07-15T12:00:00.000Z
- Updated: 2026-09-15T00:19:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141878

[**Draft Guide on Rare Disease Gene Therapies**](https://www.fdaweb.com/draft-guide-on-rare-disease-gene-therapies/)  
*Federal Register* notice: FDA makes available a draft document entitled “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.” 07/12/2018

[**Guide on CMC Info for Gene Therapy Products**](https://www.fdaweb.com/guide-on-cmc-info-for-gene-therapy-products/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications.” 07/12/2018

[**Guide on Gene Therapies for Retinal Disorders**](https://www.fdaweb.com/guide-on-gene-therapies-for-retinal-disorders/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.” 07/12/2018

[**Draft Guide on Hemophilia Gene Therapy Products**](https://www.fdaweb.com/draft-guide-on-hemophilia-gene-therapy-products/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.” 07/12/2018

[**Comments Sought on Formal PDUFA Meeting Guide**](https://www.fdaweb.com/comments-sought-on-formal-pdufa-meeting-guide/)  
*Federal Register* notice: FDA seeks comments on an information collection extension for its “Guidance on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products.” 07/11/2018

[**Draft Guide on Smallpox Antiviral Development**](https://www.fdaweb.com/draft-guide-on-smallpox-antiviral-development/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” 07/11/2018

[**Info Collection Extension for Adverse Event Reporting**](https://www.fdaweb.com/info-collection-extension-for-adverse-event-reporting-2/)  
*Federal Register* notice: FDA seeks comments on an information collection extension for “Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping” (OMB Control Number 0910-0230). 07/10/2018

[**Joint Panel to Review Fentanyl REMS Assessment**](https://www.fdaweb.com/joint-panel-to-review-fentanyl-rems-assessment/)  
*Federal Register* notice: FDA has announced an 8/3 joint Advisory Committee meeting that will discuss results from assessments of the transmucosal immediate-release fentanyl medicines’ REMS program. 07/10/2018

[**Panel to Review Insmed Lung Disease Drug**](https://www.fdaweb.com/panel-to-review-insmed-lung-disease-drug/)  
*Federal Register* notice: FDA announces an 8/7 Antimicrobial Drugs Advisory Committee meeting. 07/09/2018

[**Draft Guide on Drug Indications Labeling**](https://www.fdaweb.com/draft-guide-on-drug-indications-labeling/)  
*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**](https://www.fdaweb.com/comments-sought-on-biosimilar-info-collection/)  
*Federal Register* notice: FDA seeks comments on a information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications.” 07/09/2018