Delivery Method: Via Email Reference #: 2512 CMS 662158 Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER September 12, 2023 RE: WL 2512 Dear Elena Kraus and […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

Safety Pharmacology General safety pharmacology testing Safety pharmacology endpoints may be incorporated into general toxicity studies in order to reduce animal use. This practice is routine […]

Summary Company Announcement Date: December 26, 2025 FDA Publish Date: December 26, 2025 Product Type: Animal & VeterinaryCosmeticsDietary SupplementsDrugsFood & BeveragesMedical Devices Foodborne Illness Reason for […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-24 Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-24 […]

Delivery Method: Via Email Reference #: 320-26-29 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Zhou Yigang Recipient Title Production Manager Guangdong Renhe Guozhuang Biotechnology Co., […]