Summary Company Announcement Date: December 12, 2024 FDA Publish Date: December 13, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]

Podcast Dr. Weber: Welcome to the CDER Small Business and Industry Assistance, or SBIA, Chronicles Podcast. Today’s topic: Improving Data Quality with Centralized Statistical Monitoring My […]

Docket Number: FDA-2018-D-1216 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides detailed information and specifications for the content of the […]

[12/12/2024] Today, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center for Real-World Evidence Innovation (CCRI) which […]

What is CCRI? CCRI stands for CDER Center for Real-World Evidence Innovation. We expect CCRI to serve as a focal point for innovation and to ensure […]

The Center for Drug Evaluation and Research (CDER) Center for Real-World Evidence Innovation (CCRI) is the focal point to promote more efficient and consistent communication across […]

Reference #: FEI 2411192 Product: Drugs Recipient: Recipient Name Mr. Zachary Julius Recipient Title CEO Professional Disposables International, Inc. 4855 Pine Tree DriveMiami Beach, FL 33140United […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Zachary Julius Recipient Title Chief Executive Officer Professional Disposables International, Inc. 2 Nice-Pak ParkOrangeburg, NY 10962-1317United […]

12-12-2024 FDA Drug Safety Communication Drug Safety Communication (PDF – 221 KB) Based on its review of postmarket clinical trial data, the U.S. Food and Drug […]