Introduction to the system model of U.S.FDA warning letters
HE Hui
ZHOU Gang
Abstract：Warning letters from the U.S.FDA serve as the critical regulatory tools in the American pharmaceutical market.They are designed to supervise and ensure that the drug companies adhere to the strict production and quality standards,aiming to safeguard the consumers'health and safety.This article aims to systematically introduce the origins,legal nature,scope of application,and issuance procedures of U.S.FDA warning letters,and to explore the relevance of this system for advancing regulatory science and promoting a high-level development in drug regulation in China under new conditions.
Keywords：warning letterspharmaceutical regulationcompliance
Publication Date：2025-03-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 473-476 )