> ## 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-152/
- Published: 2017-10-15T12:00:00.000Z
- Updated: 2026-09-14T22:56:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139875

[**Draft Guide on Whether to Submit ANDA or 505(b)(2) Application**](https://www.fdaweb.com/draft-guide-on-whether-to-submit-anda-or-505-b-2-application/)  
*Federal Register* notice: FDA makes available a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 10/13/2017

[**Panel to Meet on Barricaid Anular Closure Device**](https://www.fdaweb.com/panel-to-meet-on-barricaid-anular-closure-device/)  
*Federal Register* notice: FDA announces a 12/12 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting that will discuss and vote on an Intrinsic Therapeutics PMA for the Barricaid Anular Closure Device. 10/13/2017

[**Draft Guide on Assessing Drug User Fees**](https://www.fdaweb.com/draft-guide-on-assessing-drug-user-fees/)  
*Federal Register* notice: FDA makes available a draft guidance on “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” 10/13/2017

[**Cranial Motion Measurement Devices Require 510(k): Correction**](https://www.fdaweb.com/cranial-motion-measurement-devices-require-510-k-correction/)  
*Federal Register* notice: FDA corrects a final order entitled “Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device” that appeared in the 7/28 *Federal Register*. 10/12/2017

[**PDUFA e-Submission and Data Standards Public Meeting**](https://www.fdaweb.com/pdufa-e-submission-and-data-standards-public-meeting/)  
*Federal Register* notice: FDA announces a 3/21/2018 public meeting on “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” 10/12/2017

[**Animal Generic Drug User Fee Reauthorization Meeting**](https://www.fdaweb.com/animal-generic-drug-user-fee-reauthorization-meeting/)  
*Federal Register* notice: FDA announces a 11/2 public meeting entitled “Animal Generic Drug User Fee Act.” 10/09/2017

[**Animal Drug User Fee Reauthorization Public Meeting**](https://www.fdaweb.com/animal-drug-user-fee-reauthorization-public-meeting/)  
*Federal Register* notice: FDA announces a 11/2 public meeting entitled “Animal Drug User Fee Act.” 10/09/2017

[**Regulatory Review Period Determined for Impella 2.5 System**](https://www.fdaweb.com/regulatory-review-period-determined-for-impella-2-5-system/)  
*Federal Register* notice: FDA determines the regulatory review period for patent extension purposes for Abiomed Europe’s Impella 2.5 System. 10/06/2017