FDA Defines Good Review Management; No Data In Labeling Negotiations
This article was originally published in The Tan Sheet
Executive Summary
Last-minute labeling negotiations are not an appropriate time for presentation of additional data by NDA sponsors, FDA said in a draft guidance on review practices
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Responsibility for pre-submission phase management during drug development remains with the sponsor, FDA reiterates in its final Good Review Management Principles guidance on PDUFA products
Good Review Management Guidance Focuses On PDUFA Sponsor Involvement
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