FDA regulatory affairs

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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.

The Third Edition of this highly successful publication:

Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing
Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL
Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements
Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V
Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions

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Availability

Detail Information

Series Title

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Call Number

615.19 Foo

Publisher

Boca Raton, FL : CRC Press., 2014

Collation

xii, 387 p. : ill. : ind. ; 24 cm

Language

English

ISBN/ISSN

9781841849195

Classification

NONE

Content Type

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Media Type

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Carrier Type

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Edition

3rd edition

Subject(s)

United States, Food and Drug Administration
Drug Approval--United States
United States Government Agencies--United States
Biological Products--Standards--United States
Equipment and Supplies--standards--United States
Government Regulation--United States

Specific Detail Info

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Statement of Responsibility

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Other version/related

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