Delivery Method: VIA Electronic Mail Return Confirmation Requested Product: Drugs Recipient: Recipient Name Darin Hoogendoorn Recipient Title President ARG Laboratories, Inc. 2639 Manana DriveDallas, TX 75220-1301United […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Hongbin Dai Recipient Title Chief Executive Officer of Hengrui Pharma Jiangsu Hengrui Pharmaceuticals Co., Ltd. 1288 […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER July 9, 2024 RE: 684036 Dear Kyle […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. Bian Xiangli Recipient Title Managing Director YangZhou SuXiang Medical Instrument Co., Ltd. West […]

Docket Number: FDA-2004-D-0371 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products This document provides guidance […]

Emergency Dispensing Orders | Current Emergency Dispensing Orders | Emergency Use Instructions (EUI) | Current CDC-Issued Emergency Use Information | Guidance Emergency Dispensing Orders The emergency dispensing order authority […]

Summary Company Announcement Date: July 15, 2024 FDA Publish Date: July 15, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Tainted with the drug […]

The FDA Compounding Quality Center of Excellence offers free recorded webinars to provide information on current good manufacturing practice standards, inspections and policies. Recorded Webinars Topic […]

Docket Number: FDA-2018-D-0178 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to sponsors on the clinical development of drugs […]