> ## 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-5/
- Published: 2019-12-01T12:00:00.000Z
- Updated: 2026-09-14T15:54:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145623

[**Tzvi Lexiere Debarred for 10 Years**](https://www.fdaweb.com/tzvi-lexiere-debarred-for-10-years/)  
*Federal Register* notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle and distribute misbranded drugs. 11/27/2019  

[**Six ANDAs Withdrawn by FDA**](https://www.fdaweb.com/six-andas-withdrawn-by-fda/)  
*Federal Register* notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. 11/27/2019  

[**Draft Guide on Biosimilar Clinical Immunogenicity**](https://www.fdaweb.com/draft-guide-on-biosimilar-clinical-immunogenicity/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” 11/27/2019  

[**Device Sterilization Master File Pilot**](https://www.fdaweb.com/device-sterilization-master-file-pilot/)  
*Federal Register* notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization providers to submit a master file when making certain changes. 11/26/2019  

[**Tobacco Product Modifications Compliance Policy**](https://www.fdaweb.com/tobacco-product-modifications-compliance-policy/)  
*Federal Register* notice: FDA makes available a guidance entitled “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.” 11/26/2019  

[**FDA Reopens Tobacco Product Comment Period**](https://www.fdaweb.com/fda-reopens-tobacco-product-comment-period/)  
*Federal Register* notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applications and recordkeeping requirements. 11/25/2019  

[**FDA Guidances for Generic Drug Developers**](https://www.fdaweb.com/fda-guidances-for-generic-drug-developers/)  
*Federal Register* notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug developers. 11/25/2019  

[**Info Collection for Fellowship/Trainee Programs**](https://www.fdaweb.com/info-collection-for-fellowship-trainee-programs/)  
*Federal Register* notice: FDA seeks comments on a proposed information collection for “Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” 11/25/2019