Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs-Reference-Cited by-同舟云学术

Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs

Published:2019-04 Issue:4 Volume:27 Page:571-579
ISSN:1063-4584
Container-title:Osteoarthritis and Cartilage
language:en
Short-container-title:Osteoarthritis and Cartilage

Author:

Kraus V.B.^ORCID,Simon L.S.,Katz J.N.^ORCID,Neogi T.^ORCID,Hunter D.^ORCID,Guermazi A.,Karsdal M.A.^ORCID

Publisher

Elsevier BV

Subject

Orthopedics and Sports Medicine,Biomedical Engineering,Rheumatology

Reference21 articles.

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3. Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics;Food and Drug Administration,2014

4. Food and Drug Administration Safety and Innovation Act,2012

5. 21st Century Cures Act,2016

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