FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics / edited by Douglas J. Pisano, David S. Mantus.

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 co...

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Bibliographic Details
Online Access: Full Text (via Taylor & Francis)
Other Authors: Pisano, Douglas J., Mantus, David
Format: eBook
Published: New York : Informa Healthcare USA, ©2008.
Edition:2nd ed.
Table of Contents:
  • Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano
  • What is an IND / Charles Monahan and Josephine C. Babiarz
  • Meeting with the FDA / Alberto Grignolo
  • FDA medical device regulation / Barry Sall
  • The development of orphan drugs / Tan T. Nguyen
  • CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke
  • Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks
  • FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake
  • Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman
  • The practice of regulatory affairs / David S. Mantus
  • A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz
  • FDA advisory committees / Christina A. McCarthy and David S. Mantus
  • Biologics / Timothy A. Keutzer.