> ## 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-162/
- Published: 2018-01-15T12:00:00.000Z
- Updated: 2026-09-14T23:13:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140506

[**Regulatory Review Period Determined for Uromedica’s Proact**](https://www.fdaweb.com/regulatory-review-period-determined-for-uromedicas-proact/)  
*Federal Register* notice: FDA determines that the regulatory review period for Uromedica’s Proact Adjustable Continence Therapy For Men was 3,892 days. 01/12/2018

[**Comments Extended for Guide on Submitting ANDA/505(b)(2)**](https://www.fdaweb.com/comments-extended-for-guide-on-submitting-anda-505-b-2/)  
*Federal Register* notice: FDA reopens the comment period until 2/12 on a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 01/12/2018

[**Comments Extended on Orphan Drug Guidance**](https://www.fdaweb.com/comments-extended-on-orphan-drug-guidance/)  
*Federal Register* notice: FDA extends the comment period on a draft guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” 01/12/2018

[**FDA Advisory Panel to Review Pacira sNDA for Exparel**](https://www.fdaweb.com/fda-advisory-panel-to-review-pacira-snda-for-exparel/)  
*Federal Register* notice: FDA announces a 2/14-15 Anesthetic and Analgesic Drug Products Advisory Committee meeting to review a Pacira Pharmaceuticals supplemental NDA for Exparel. 01/11/2018

[**Info Collection Extension Sought for Application Certifications**](https://www.fdaweb.com/info-collection-extension-sought-for-application-certifications/)  
*Federal Register* notice: FDA requests OMB clearance for an information collection extension for “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) OMB Control Number 0910-0616.” 01/11/2018

[**Regulatory Review Period Determined for Entyce**](https://www.fdaweb.com/regulatory-review-period-determined-for-entyce/)  
*Federal Register* notice: FDA determines that the regulatory review period for RaQualia Pharma’s Entyce (capromorelin), indicated for appetite stimulation in dogs, was 1,645 days. 01/11/2018

[**Risk Communication Panel to Discuss Pregnancy/Lactation Labeling**](https://www.fdaweb.com/risk-communication-panel-to-discuss-pregnancy-lactation-labeling/)  
*Federal Register* notice: FDA announces a 3/5-6 Risk Communication Advisory Committee meeting to discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products. 01/10/2018