OARSI Clinical Trials Recommendations: An abbreviated regulatory guide to the clinical requirements for development of therapeutics in osteoarthritis

Summary In this brief abbreviated review of regulatory issues regarding the development of drugs and or devices for the treatment of osteoarthritis (OA), the steps that are expected by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are discussed.

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Bibliographic Details
Published in:Osteoarthritis and cartilage 2015-05, Vol.23 (5), p.674-676
Main Author: Simon, L.S
Format: Article
Language:English
Subjects:
Clinical Trials as Topic - standards
Disease Management
EMA
Europe
FDA
Humans
Osteoarthritis - therapy
Osteoarthritis therapeutics
Practice Guidelines as Topic
Regulatory
Rheumatology
United States
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Description
Summary:Summary In this brief abbreviated review of regulatory issues regarding the development of drugs and or devices for the treatment of osteoarthritis (OA), the steps that are expected by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are discussed.
ISSN:1063-4584
1522-9653
DOI:10.1016/j.joca.2015.03.010