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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 […]
December 11, 2020

iThrive.health – 611790 – 12/10/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States Date:   December 10, 2020 TO:             rio.zavar[email protected]  – Alirio Zavarce, iThrive.Health     CC:  [email protected] – Amazon Associates […]
December 10, 2020

Coronavirus (COVID-19) Update: December 10, 2020

For Immediate Release: December 10, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
December 10, 2020

UPDATED TIME INFORMATION: December 16, 2020 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement – 12/16/2020 – 12/16/2020

On This Page Date: December 16, 2020 Time: 9:00 AM – 2:00 PM ET UPDATED INFORMATION (as of 12/09/2020): The meeting time has changed to 9 […]
December 10, 2020

FDA Will Test Ability to Receive Digital Annotated ECG Waveform Files as Agency Prepares to Transition to New ECG Warehouse

Individuals can test the new system’s capability by submitting annotated ECG files [12/10/2020] The U.S. Food and Drug Administration is now testing its capability to receive […]
December 9, 2020

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure

Summary Company Announcement Date: December 09, 2020 FDA Publish Date: December 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to dissolution test […]
December 9, 2020

AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

Summary Company Announcement Date: December 09, 2020 FDA Publish Date: December 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to product mix-up […]
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