CDER Takes A Micro/Macro Approach To Monitoring ‘Breakthrough’ Programs

11 Aug 2014
News

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

Agency staff will conduct high-level reviews every three to six months to assess adequacy of individual development programs, while the Medical Policy Council will undertake portfolio reviews across breakthrough-designated products.

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Industries
BioPharmaceutical
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North America

United States

Subjects
Regulation

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CDER Takes A Micro/Macro Approach To Monitoring ‘Breakthrough’ Programs

News

Executive Summary

Related Content

‘Breakthrough’ Drugs Get ‘Road-MaPP’ – Complete With Communication Timetable

CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues

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