| OBJECTIVE：To study the key points of American drug shortage management strategy, and provides reference for the drug shortage management of China. METHODS：The official websites of FDA were retrieved to find related documents, laws and regulations, the drug shortage data between 2010-2018 were summarized, and the drug shortage regulatory strategy was researched. RESULTS：An interagency Drug Shortages Task Force was established to advance long-term solutions to prevent shortages, the CDER"s Manual of Policies and Procedures for drug shortage management was reviewed, countermeasures as strengthen drug quality management, maintain market competition, assurance supply chain stability, multi-institutional collaborations and advocate social co-governance, etc, had been taken by the regulatory agency, the strategy of using of legal thinking and legal methods to improve the level of drug shortage management was emphasized. CONCLUSION：The experience and further plan of American in dealing with drug shortage were still useful for the drug shortage management of China. |