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 […]

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only […]

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 […]

We reviewed cases from U.S. poison control center calls and published articles in the medical literature1,2 of serious ocular adverse events following accidental ocular exposure to […]