FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition / Edition 2

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition / Edition 2

by Douglas J. Pisano
     
 

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a

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Overview

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

FDA Regulatory Affairs:


  • provides a blueprint to the FDA and drug, biologic, and medical device development
  • offers current, real-time information in a simple and concise format
  • contains a chapter highlighting the new drug application (NDA) process
  • discusses FDA inspection processes and enforcement options
  • includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA

Three all-new chapters cover:


  • clinical trial exemptions
  • advisory committees
  • provisions for fast track

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Product Details

ISBN-13:
9781420073546
Publisher:
Taylor & Francis
Publication date:
08/07/2008
Edition description:
REV
Pages:
464
Product dimensions:
6.00(w) x 9.50(h) x 1.00(d)

Table of Contents

Ch.1 - Overview Of Drug Development And The FDA: Josephine Babiarz

Ch.2 - IND: Michael R. Hamrell

Ch.3 - Formatting, Assembling, And Submitting A CTD (NDA): Charles Monahan III

Ch.4 - Meeting with the FDA: Alberto Grignolo

Ch.5 – Biologics: J. Kenimer

Ch.6 - FDA Medical Device Regulation: Barry Sall

Ch.7 - The Development of Orphan Drugs: Tan Nguyen

Ch.8 - Chemistry, Manufacturing and Control Issues: Drugs and Biologics: Prabu Nambiar

Ch. 9 - Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices: Robert Buckley

Ch.10 - The Regulation of Promotional Materials And Advertising For Drugs: Karen Drake

Ch.11 - CTD SUBMISSIONS: A Guide For Electronic Regulatory Submissions to FDA: Shylendra Kumar, Yolanda Hall, Vahé Ghahraman

Ch.12 - The Practice Of Regulatory Affairs: Dave Mantus

Ch. 13 - A Primer Of Drug/Device Law Or What's The Law And How Do I Find It? Josephine Babiarz

Ch.14 - Advisory Committee System at FDA: Christina McCarthy

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