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US FDA��s New Measures for Strengthening Drug Safety Administration

??OBJECTIVE US FDA??s drug safety regulatory new initiatives was interpreted and analyzed to provide lessons for China??s drug administration. METHODS By interpreting US FDA??s relevant guidelines on drug safety administration, the measures on strengthening the safety administration, risk assessment and post-market surveillance were introduced and discussed. RESULTS Lessons was learned by analyzing the successful experiences of FDA drug safety administration and risk management. CONCLUSION China??s drug administration need to take steps to keep focus narrow, attach importance to administrative methodology and innovate policies based on the lessons from US FDA and China??s current drug regulatory conditions.