> ## 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-197/
- Published: 2018-09-30T12:00:00.000Z
- Updated: 2026-09-15T00:34:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142486

[**Former Able Labs Quality Manager Debarred**](https://www.fdaweb.com/former-able-labs-quality-manager-debarred/)  
*Federal Register* notice: FDA denies a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing services in any capacity to a person that has an approved or pending drug product application. 09/28/2018

[**FDA Reclassifies Single-use Female Condoms**](https://www.fdaweb.com/fda-reclassifies-single-use-female-condoms/)  
*Federal Register* notice: FDA issues a final order to reclassify single- use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device into Class 2 (special controls) subject to premarket notification (510(k)). 09/28/2018

[**Comments Reopened on Coronary Stent Guides**](https://www.fdaweb.com/comments-reopened-on-coronary-stent-guides/)  
*Federal Register* notice: FDA reopens the comment period related to two draft guidance documents on coronary drug-eluting stents. 09/27/2018

[**FDA Withdraws Approval for 7 ANDAs**](https://www.fdaweb.com/fda-withdraws-approval-for-7-andas/)  
*Federal Register* notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency in writing that the drug products were no longer marketed. 09/27/2018

[**Draft Guide on Compounding Insanitary Conditions**](https://www.fdaweb.com/draft-guide-on-compounding-insanitary-conditions/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Insanitary Conditions at Compounding Facilities.” 09/27/2018

[**Guide on Radiopharmaceuticals from Outsourcing Facilities**](https://www.fdaweb.com/guide-on-radiopharmaceuticals-from-outsourcing-facilities/)  
*Federal Register* notice: FDA makes available a final guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.” 09/27/2018

[**Countermeasure Priority Review Voucher Fee $2.5 Million**](https://www.fdaweb.com/countermeasure-priority-review-voucher-fee-2-5-million/)  
*Federal Register* notice: FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2019 — $2,457,140\. 09/27/2018