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Biopharma industry representatives are taking issue with some of the FDA’s more political proposals in the next round of user fee agreements, particularly ones that would limit the small business waiver to only US applicants and reduce user fees for companies that run their Phase 1 trials in the US.
生物制药行业代表对FDA在下一轮用户付费协议中的一些更具政治色彩的提议提出异议,尤其是不再向非美国申请者提供小企业减免、并对在美国开展一期临床试验的公司降低用户费用等提案。
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