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BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications

December 18, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff.

BIO appreciates the effort to update and release the guidance to inform industry, sponsors, and FDA staff and reviewers about regulatory review practices. This will support a more efficient and transparent review of new therapies. BIO provides suggestions on how to strengthen the document and communications, and ensure all stakeholders have appropriate information and resources.

 

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BIO Comment Letter FDA Draft Guidance On Good Review Principles And Practices For NDAs And BLAs FDA-2018-D-3103
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