> ## 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-165/
- Published: 2018-02-04T12:00:00.000Z
- Updated: 2026-09-14T23:19:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140684

[**Regulatory Review Period Set for Edwards’ Sapien Valve**](https://www.fdaweb.com/regulatory-review-period-set-for-edwards-sapien-valve/)  
*Federal Register* notice: FDA determines for patent extension purposes that the regulatory review period for Edwards Lifesciences’ Sapien XT Transcatheter Heart Valve is 1,370 days. 02/02/2018

[**Workshop on Modeling/Simulation for Oncology Products**](https://www.fdaweb.com/workshop-on-modeling-simulation-for-oncology-products/)  
*Federal Register* notice: FDA announced a 2/1 public workshop entitled “Best Practices in Modeling and Simulation for Oncology Products.” 02/01/2018

[**Regulatory Review Period Determined for Corlanor**](https://www.fdaweb.com/regulatory-review-period-determined-for-corlanor/)  
*Federal Register* notice: FDA determines that for patent extension purposes the regulatory review period for Les Laboratoires Servier’s Corlanor (ivabradine hydrochloride) was 293 days. 02/01/2018

[**Regulatory Review Period Determined for Merck’s Keytruda**](https://www.fdaweb.com/regulatory-review-period-determined-for-mercks-keytruda/)  
*Federal Register* notice: FDA determines for patent extension purposes the regulatory review period for Merck’s Keytruda (pembrolizumab) to be 1,338 days. 01/31/2018

[**Meeting on Trial Inclusion/Exclusion Criteria**](https://www.fdaweb.com/meeting-on-trial-inclusion-exclusion-criteria/)  
*Federal Register* notice: FDA plans a 4/16 public meeting on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” 01/31/2018

[**Draft Guide on Qualified Infectious Disease Designations**](https://www.fdaweb.com/draft-guide-on-qualified-infectious-disease-designations-2/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Qualified Infectious Disease Product Designation Questions and Answers.” 01/30/2018

[**Surgical Smoke Precipitator Put Into Class 2**](https://www.fdaweb.com/surgical-smoke-precipitator-put-into-class-2/)  
*Federal Register* notice: FDA classifies the surgical smoke precipitator into Class 2 (special controls). 01/30/2018

[**Class 2 for Embolic Protection Temporary Catheter**](https://www.fdaweb.com/class-2-for-embolic-protection-temporary-catheter/)  
*Federal Register* notice: FDA classifies the temporary catheter for embolic protection during transcatheter intracardiac procedures into Class 2 (special controls). 01/30/2018

[**Comments Sought on WHO Restrictions for Certain Narcotics**](https://www.fdaweb.com/comments-sought-on-who-restrictions-for-certain-narcotics/)  
*Federal Register* notice: FDA provides interested parties with the opportunity to submit written comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on certain drug substances. 01/29/2018