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10.3389/fphar.2019.01684 179 ZhangY.ZhenS.XuH.SunS.WangZ.LiM.et al (2024)

doi: 10.1007/BF01852257

We proposed to add new 414.804(a)(5)(iii) requiring manufacturers to provide certification letters from any recipient of a BFSF that the fee is not passed on in whole or in part to an affiliate, client or customer of an entity, whether or not the entity takes title to the drug