FDA ANDA审评中变更指南定稿

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FDA Releases ANDA Submission Guidance

The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
Jul 03, 2018
By Pharmaceutical Technology Editors

On July 3, 2018, FDA released final guidance regarding the submission of amendments to abbreviated new drug application (ANDA) submissions. The guidance document is intended to explain how the review goals in the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to ANDA submissions or prior approval supplements (PASs).

Amendment classifications and categories are discussed in the document. The guidance also explains how amendment submissions may affect review goal dates. FDA’s assessment of amendments submitted to ANDAs and PASs received prior to October 1, 2017 is also addressed. An appendix provides examples of deficiencies that FDA may consider to be major.

http://www.pharmtech.com/fda-releases-anda-submission-guidance-5

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Final Guidance on ANDA and Supplement Amendments Hits the NewsstandsBy Bob Pollock

| July 4, 2018 | FDA, Generics, Regulatory Affairs | Like |

syhorchid

谢谢分享

beiwei5du

syhorchid 发表于 2018-7-4 13:37
谢谢分享

不用谢，你可不可以不用回复，这样也节省你的时间