> ## 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-224/
- Published: 2019-05-19T12:00:00.000Z
- Updated: 2026-09-15T01:27:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144147

[**Info Collection Extension for Drug Patent Listings**](https://www.fdaweb.com/info-collection-extension-for-drug-patent-listings/)  
*Federal Register* notice: FDA seeks comments on an information collection extension for “Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements.” 05/17/2019

[**Fed Reg Correction on Device Accessories**](https://www.fdaweb.com/fed-reg-correction-on-device-accessories/)  
*Federal Register* notice: FDA corrects a 4/12 Federal Register notice on the classification of medical device accessories distinct from other devices, which included a finalized list of accessories suitable for Class 1\. 05/17/2019

[**ANDA Product-specific Bioequivalence Guides**](https://www.fdaweb.com/anda-product-specific-bioequivalence-guides/)  
*Federal Register* notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence study designs. 05/15/2019

[**Guide on Demonstrating Biosimilar Interchangeability** ](https://www.fdaweb.com/guide-on-demonstrating-biosimilar-interchangeability/)*Federal Register* notice: FDA makes available a final guidance entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” 05/14/2019

[**Regulatory Review Period for Gore’s Viabahn**](https://www.fdaweb.com/regulatory-review-period-for-gores-viabahn/)  
*Federal Register* notice: FDA determines the regulatory review period for W.L. Gore & Associates’ Gore Viabahn VBX Balloon Expandable Endoprosthesis. 05/13/2019

[**Meeting on User Fee Financial Transparency**](https://www.fdaweb.com/meeting-on-user-fee-financial-transparency-2/)  
*Federal Register* notice: FDA announces a 6/7 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” 05/13/2019

[**Regulatory Review Period for Austedo**](https://www.fdaweb.com/regulatory-review-period-for-austedo/)  
*Federal Register* notice: FDA determines the regulatory review period for Auspex Pharmaceuticals’s Austedo (deutetrabenazine), indicated for treating chorea associated with Huntington’s disease. 05/13/2019

[**Guide on Submitting ANDA or 505(b)(2) NDA**](https://www.fdaweb.com/guide-on-submitting-anda-or-505-b-2-nda/)  
*Federal Register* notice: FDA makes available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 05/10/2019