林业发展局现在允许大多数新药只根据一次临床试验获得批准,以加快获取途径和降低成本。
The FDA now allows most new drugs to be approved based on just one clinical trial to speed up access and lower costs.
林业发展局修订了其药物批准程序,允许大多数新药根据单一临床试验而不是传统的两种试验获得批准,并列举了科学和数据分析的进展。
The FDA has revised its drug approval process, allowing most new drugs to be approved based on a single clinical trial instead of the traditional two, citing advances in science and data analysis.
这一立即生效的变革旨在加快获得治疗的机会,降低发展成本,降低药物价格,特别是在罕见和严重的条件下。
The change, effective immediately, aims to speed up access to treatments, reduce development costs, and lower drug prices, particularly for rare and serious conditions.
虽然该机构保持了严格的安全标准,仍然需要在批准后进行更多的研究,但专家在转变是提高效率还是危及病人安全方面仍然意见不一。
While the agency maintains strong safety standards and can still require additional studies post-approval, experts remain divided on whether the shift improves efficiency or risks patient safety.