Original paper

Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk Ratio

Volume: 55, Issue: 1, Pages: 129 - 137
Published: Jul 8, 2020
Abstract
Background Approval of regulated medical products in the USA is based upon a rigorous review of the benefits and risks as performed by the US Food and Drug Administration (FDA) staff of scientists and is summarized in a descriptive and qualitative format called the FDA’s Benefit–Risk Framework (BRF). This present method highlights the key factors in regulatory decision-making, but does not clearly define the reason for its final approval. Method...
Paper Details
Title
Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk Ratio
Published Date
Jul 8, 2020
Volume
55
Issue
1
Pages
129 - 137
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