Description

Book Synopsis

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 correspond

FDA Regulatory Affairs

    Product form

    A Paperback by David Mantus

    £43.69

    Includes FREE delivery

    RRP £45.99 – you save £2.30 (5%)

    Order before 4pm today for delivery by Tue 6 Oct 2026.

    1 in stock

      Trusted by thousands of customers. See 2,385+ Customer Reviews

      View other formats and editions of FDA Regulatory Affairs by David Mantus

      Book details

      Publisher CRC Press
      Published 10/14/2024
      ISBN-13 9781032920542
      978-1032920542
      ISBN-10 1032920548
      Also in:
      Education Medicine / Healthcare: general issues / topics

      Description

      Book Synopsis

      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 correspond

      Recently viewed products

      © 2026 Book Curl

        • American Express
        • Apple Pay
        • Diners Club
        • Discover
        • Google Pay
        • Maestro
        • Mastercard
        • PayPal
        • Shop Pay
        • Union Pay
        • Visa

        Login

        Forgot your password?

        Don't have an account yet?
        Create account