什么是What is 505(b)(2)?

[Tlexander]

What is 505(b)(2)?

The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.

A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.

[Tlexander]

505(b)(1) NDA
Full application – Data predominantly obtained from studies conducted by and for the sponsor

505(b)(2) NDA
Hybrid between an ANDA (505(j)) and full NDA (505(b)(1))

505 (j) ANDA
Appropriate for drug products that are the same as approved products

[CutPaste]

What is 505(b)(2)?

The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.

A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.

律师就会指导西药厂预先布局，拿钱预买相关成分的研究。

这些研究的报告当然是肯定了成分的安全性和有效有利性。

然后FDA自然眨眨眼默契的名正言顺的批准不安全的新药。

总之，只要FDA能有预先安排好的借口和下阶梯，就批准。

这漏洞使FDA，西药厂和医疗业利益各取所需，皆大欢喜。

实际后果就是病人和消费者变付钱的小白鼠，纳税人买单。

最怕国内的西医疗业也在“与时俱进”响亮口号下模仿米疣。





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