美国食品和药物管理局将从两项临床试验转变为一项, FDA to shift from two to one clinical trial for most new drug approvals to accelerate access.

美国食品和药物管理局计划取代其几十年来对新药批准的两项临床试验的要求, 以一个研究的默认标准, 旨在加快获得治疗的速度. The FDA plans to replace its decades-old requirement of two clinical trials for new drug approvals with a default standard of one study, aiming to speed up access to treatments. 这一变化是由科学和数据分析的进展推动的,它建立在稀有和威胁生命的疾病的现有灵活性的基础之上,在这些疾病中,单次试验已经批准了大约60%的首次药物。 The change, driven by advances in science and data analysis, builds on existing flexibility for rare and life-threatening diseases, where single trials already approve about 60% of first-time drugs. 虽然安全标准仍然很高,但这一转变可能会减少发展时间和费用,特别是对于共同的条件而言。 While safety standards remain high, the shift may reduce development time and costs, especially for common conditions. 然而,对疫苗和基因疗法继续提出更严格的要求,强调不同产品类别应用不一致。 However, stricter requirements continue for vaccines and gene therapies, highlighting inconsistent application across product types.