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December 15, 2020

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products

Docket Number: FDA-2019-D-3679 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This document provides guidance to sponsors […]
December 15, 2020

Smoky Mountain Naturals, LLC – 609235 – 12/02/2020

Delivery Method: United Parcel Service Product: Drugs Recipient: Recipient Name Daniel Jetton Smoky Mountain Naturals, LLC 3605 Nebraska AvenueNashville, TN 37209United States Issuing Office: Division of […]
December 15, 2020

GOJO Industries Inc – 599132 – 11/30/2020

Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Carey Jaros Recipient Title President & CEO GOJO Industries Inc 3783 State RoadCuyahoga Falls, OH 44223-2603United […]
December 14, 2020

Coronavirus (COVID-19) Update: December 14, 2020

For Immediate Release: December 14, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
December 11, 2020

Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables Due to a Lack of Sterility Assurance

Summary Company Announcement Date: November 05, 2019 FDA Publish Date: November 05, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance […]
December 11, 2020

Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance

Summary Company Announcement Date: October 25, 2019 FDA Publish Date: October 26, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of foreign […]
December 11, 2020

Public Posting of a Comprehensive Surrogate Endpoint Table for CDER- and CBER-Regulated Products

The public posting of a surrogate endpoint (SE) table for both reasonably likely and validated SEs was mandated by the 21st Century Cures Act of 2016 […]
December 11, 2020

Heavenly Natural Products – 607470 – 12/02/2020

Product: Dietary SupplementsDrugs Recipient: Heavenly Natural Products 100 Monroe St #406Centerton, AR 72719United States Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States […]
December 11, 2020

Indigenous Products – 610588 – 12/10/2020

Product: Drugs Recipient: Recipient Name Steve Crear Indigenous Products Dallas, TX 75232United States [email protected] Issuing Office: Center for Drug Evaluation and Research | CDER United States […]
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