> ## 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-167/
- Published: 2018-02-19T12:00:00.000Z
- Updated: 2026-09-14T23:23:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140788

[**Public Meeting on Pediatric Device Development**](https://www.fdaweb.com/public-meeting-on-pediatric-device-development/)  
*Federal Register* notice: FDA announces an 8/13-14 public meeting entitled “Pediatric Medical Device Development.” 02/16/2018

[**Guide on How to Prepare Combination Product Designation Request**](https://www.fdaweb.com/guide-on-how-to-prepare-combination-product-designation-request/)  
*Federal Register* notice: FDA makes available a guidance entitled “How to Prepare a Pre-Request for Designation (Pre-RFD).” 02/16/2018

[**Lotensin HCT Not Withdrawn Due to Safety/Efficacy**](https://www.fdaweb.com/lotensin-hct-not-withdrawn-due-to-safety-efficacy/)  
*Federal Register* notice: FDA determines that U.S. Pharmaceutical Holdings’ Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. 02/16/2018

[**Draft Guide on eSubmission Data for BIMO Inspection Prep**](https://www.fdaweb.com/draft-guide-on-esubmission-data-for-bimo-inspection-prep/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections for CDER Submissions.’’ 02/16/2018

[**Panel to Review Akcea Therapeutics NDA in May**](https://www.fdaweb.com/panel-to-review-akcea-therapeutics-nda-in-may/)  
*Federal Register* notice: FDA announces a 5/10 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review Akcea Therapeutics NDA. 02/16/2018

[**Oncologic Drugs Panel Meeting to Review Amgen sBLA**](https://www.fdaweb.com/oncologic-drugs-panel-meeting-to-review-amgen-sbla/)  
*Federal Register* notice: FDA announces a 3/7 Oncologic Drugs Advisory Committee meeting to review Amgen supplemental BLA for Blincyto. 02/15/2018

[**Guide on Pharmaceutical Co-Crystals**](https://www.fdaweb.com/guide-on-pharmaceutical-co-crystals/)  
*Federal Register* notice: FDA makes available a guidance entitled “Regulatory Classification of Pharmaceutical Co-Crystals.” 02/15/2018

[**Hemostatic Gauze Placed in Class 2**](https://www.fdaweb.com/hemostatic-gauze-placed-in-class-2/)  
Federal Register notice: FDA classifies the non-absorbable, hemostatic gauze for temporary internal use into Class 2 (special controls). 02/15/2018

[**Proposed Rule on Animal Drug ADR eSubmissions**](https://www.fdaweb.com/proposed-rule-on-animal-drug-adr-esubmissions/)  
*Federal Register* proposed rule: FDA proposes to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted in an electronic format. 02/14/2018

[**Workshop on Rare Disease Statistical Methods/Trial Designs** ](https://www.fdaweb.com/workshop-on-rare-disease-statistical-methods-trial-designs/)*Federal Register* notice: FDA announces a 3/19 workshop on “Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.” 02/14/2018