The Pharmaceutical Regulatory Process

2nd Edition

Ira R. Berry, Robert P. Martin

CRC Press
Published December 2, 2008
Reference - 650 Pages - 35 B/W Illustrations
ISBN 9781420070422 - CAT# H7042
Series: Drugs and the Pharmaceutical Sciences

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Summary

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

New chapters cover:

  • the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
  • pharmacovigilance programs designed to prevent widespread safety issues
  • legal issues surrounding the sourcing of foreign APIs
  • the issues of counterfeit drugs
  • updates on quality standards

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