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FDA Regulatory Affairs, 3rd Edition / Mantus, David & Pisano, Douglas J. (Eds.)
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FDA Regulatory Affairs, 3rd Edition
Mantus, David & Pisano, Douglas J. (Eds.)
 
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List Price : US$ 134.39
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  Book ID : 25938
  ISBN-10 : 1-138-09873-6 / 1138098736
  ISBN-13 : 978-1-138-09873-2 / 9781138098732
  Place of Publication :
  Year of Publication : 2014
  Edition : (Third Edition) (South Asian Edition)
  Language : English
  400p.
   
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 CONTENTS
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 DESCRIPTION
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FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.
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