What is it about?
looking at what factors contribute to earlier approval of generic drug applications
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Why is it important?
getting better understanding of how to get faster approvals will increase access to safe, effective and affordable drug products
Perspectives
we are using newer metrics and analysis to determine what factors affect generic drug approval, rather than just waiting to see how long it takes to get applications approved
Jason Woo
US Food and Drug Administration
Read the Original
This page is a summary of: Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics, Therapeutic Innovation & Regulatory Science, October 2018, SAGE Publications,
DOI: 10.1177/2168479018806192.
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