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Chapter-06 Medical Devices—Regulations and Research

BOOK TITLE: Drug Discovery and Clinical Research

Author
1. Das Saurendra
ISBN
9789350252727
DOI
10.5005/jp/books/11216_6
Edition
1/e
Publishing Year
2011
Pages
13
Author Affiliations
1. Excel Lifesciences, B-155, Sector-63, Noida, Uttar Pradesh, India, Excel Life Sciences Inc., Noida, Uttar Pradesh, India
Chapter keywords
Pharmacopoeia, medical devices, pharmacoeconomic studies, Schedule M-III requirements, global harmonization task force (GHTF), feasibility studies, Global Harmonization Task Force, Schedule M-III – requirements, Food and Drug Administration, GHTF definition, Packaging and Labeling, Advertising, phase of clinical development, feasibility studies of safety, pilot studies, pivotal studies, Postmarketing studies, Postmarketing surveillance studies, US regulations, Medical devices directive, medical device safety

Abstract

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