The Pharmaceutical Regulatory Process
eBook - PDF

The Pharmaceutical Regulatory Process

  1. 650 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

The Pharmaceutical Regulatory Process

About this book

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, an

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Yes, you can access The Pharmaceutical Regulatory Process by Ira R. Berry, Robert P. Martin, Ira R. Berry,Robert P. Martin in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2008
Print ISBN
9780367202842
eBook ISBN
9781420070439
Edition
2
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. Title Page
  3. Preface
  4. Contents
  5. Chapter 1- Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act
  6. Chapter 2- Modernizing the Food and Drug Administration
  7. Chapter 3- The New Drug–Approval Process—Before and After 1962
  8. Chapter 4- Generic Drug-Approval Process: Hatch–Waxman Update
  9. Chapter 5- FDA Regulation of Biological Products
  10. Chapter 6- FDA’s Antibiotic Regulatory Scheme: Then and Now
  11. Chapter 7- Generic Drugs in a Changing Intellectual Property Landscape
  12. Chapter 8- The Influence of the Prescription Drug User Fee Act on the Approval Process
  13. Chapter 9- Clinical Research Requirements for New Drug Applications
  14. Chapter 10- Postapproval Marketing Practices Regarding Drug Safety and Pharmacovigilance
  15. Chapter 11- Drugs Marketed Without FDA Approval
  16. Chapter 12- FDA Regulation of Foreign Drug Imports: The Need for Improvement
  17. Chapter 13- Active Pharmaceutical Ingredients
  18. Chapter 14- Obtaining Approval of New Drug Applications and Abbreviated New Drug Applications from a Chemistry, Manufacturing, and Controls Perspective
  19. Chapter 15- Obtaining Approval of a Generic Drug, Pre-1984 to the Present
  20. Chapter 16- New Developments in the Approval and Marketing of Nonprescription or OTC Drugs
  21. Chapter 17- Current Good Manufacturing Practice and the Drug Approval Process
  22. Chapter 18- The Influence of the USP on the Drug Approval Process
  23. Chapter 19- Ways, Means, and Evolving Trends in the U.S. Registration of Drug Products from Foreign Countries
  24. Chapter 20- Impact of Government Regulation on Prescription Drug Marketing and Promotion
  25. Chapter 21- CMC Postapproval Regulatory Affairs: Constantly Managing Change
  26. Chapter 22- Living with 21 CFR Part 11 Compliance
  27. Index
  28. Back Cover