> ## 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-209/
- Published: 2019-02-03T12:00:00.000Z
- Updated: 2026-09-15T00:59:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143292

[**Rare Disease Drug Development Guide**](https://www.fdaweb.com/rare-disease-drug-development-guide/)  
*Federal Register* notice: FDA issues a draft guidance, Rare Diseases: Common Issues in Drug Development, to assist drug and biological sponsors in conducting more efficient and successful drug development programs. 02/01/2019

[**Guide on REMS Assessment: Planning and Reporting**](https://www.fdaweb.com/guide-on-rems-assessment-planning-and-reporting/)  
*Federal Register* notice: FDA makes available a draft guidance entitled REMS Assessment: Planning and Reporting. 02/01/2019

[**Coordinating Antimicrobial Drug/Susceptibility Test Guide**](https://www.fdaweb.com/coordinating-antimicrobial-drug-susceptibility-test-guide/)  
*Federal Register* notice: FDA makes available a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” 02/01/2019

[**Guide on Device Safety/Performance-based Pathway**](https://www.fdaweb.com/guide-on-device-safety-performance-based-pathway/)  
*Federal Register* notice: FDA issues a guidance, Safety and Performance Based Pathway, that discusses the agency’s current thinking on expanding the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. 02/01/2019

[**Guide on REMS Survey Methodologies**](https://www.fdaweb.com/guide-on-rems-survey-methodologies/)  
*Federal Register* notice: FDA releases a draft guidance entitled Survey Methodologies to Assess REMS Goals That Relate to Knowledge that gives information to industry on conducting REMS assessment surveys. 02/01/2019

[**Draft Guide on Drug Marketing Status Notifications**](https://www.fdaweb.com/draft-guide-on-drug-marketing-status-notifications/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” 01/31/2019

[**Neurological Devices Panel Meeting on Alzheimer’s Device**](https://www.fdaweb.com/neurological-devices-panel-meeting-on-alzheimers-device/)  
Federal Register notice: FDA announces a 3/21 Neurological Devices Panel of the Medical Devices Advisory Committee meeting that will review a de novo request for the NeuroAD Therapy System for Alzheimer’s dementia. 01/31/2019

[**Panel to Review Pre-Pen Plus Skin Test**](https://www.fdaweb.com/panel-to-review-pre-pen-plus-skin-test/)  
*Federal Register* notice: FDA announces a 3/27 Pulmonary-Allergy Drugs Advisory Committee meeting. to discuss a AllerQuest NDA for Pre-Pen Plus, a skin-test kit for determining sensitization to penicillin. 01/31/2019