A 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 and was achieved in July 2018. The SE table increases transparency by informing stakeholders about the development of...SBIA Chronicles
Improving Data Quality with Centralized Statistical Monitoring – with Dr. Paul Schuette and Xiaofeng (Tina) WangDecember 13, 2024 Podcast(12:30 min, 17.2MB, MP3)TranscriptThe Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert BallNovember 14,...DermaRite Industries, LLC – 710997
Delivery Method: VIA UPS Reference #: 320-26-09 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Fabian McCarthy DermaRite Industries, LLC 7777 West Side AvenueNorth Bergen, NJ 07047United States Issuing Office: Center for Drug Evaluation and...World Perfumes Inc. – 713958
Delivery Method: VIA UPS Reference #: 320-26-10 Product: Drugs Recipient: Recipient Name Ms. Ivania S. Gutierrez Recipient Title President World Perfumes Inc. 2360 NW 150th StreetOpa-Locka, FL 33054-2706United States Issuing Office: Center for Drug Evaluation and...Uriel Pharmacy, Inc. – 709977
Delivery Method: VIA UPS Reference #: 320-26-08 Product: Drugs Recipient: Recipient Name Mr. Mark S. McKibben Recipient Title President Uriel Pharmacy, Inc. N8464 Sterman Rd.East Troy, WI 53120United States Issuing Office: Center for Drug Evaluation and Research...All Drug Purchases Are
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