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FDA Regulatory Affairs

FDA Regulatory Affairs
Books from same Author: Mantus
Books from same Publisher: Taylor & Francis (CRC)

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Key Features
  • Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulat
  • Includes contributions from experts at organizations such as the FDA, National Institutes of Health
  • Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corre
  • Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines a
  • Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and r
Description

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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General Information
Author(s)Mantus
PublisherTaylor & Francis (CRC)
Edition3
ISBN9781841849195
Pages400
BindingHardcover
LanguageEnglish
Publish YearJanuary 2014
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