By analyzing the foundations of pharmaceutical industry regulation and current legal, regulatory, and compliance developments, the new 2023 Edition of Pharmaceutical Compliance and Enforcement Answer Book provides a framework for understanding the rigorous and frequently overlapping requirements imposed by various governmental authorities and private parties upon the pharmaceutical industry that constitute the enforcement environment.

In a reader-friendly Q&A format, this resource discusses topics such as:
• The Role of the FDA in Drug Development; 
• 483s and Warning Letters; 
• Regulation and Compliance for Dissemination of Medical Information;
• Off-Label Promotion; 
• Risk Evaluation and Mitigation Strategies (REMS); 
• Product Liability Exposure for Pharmaceutical Manufacturers; and 
• The FCPA and the Pharmaceutical Industry.

The 2023 edition also includes new chapters on Over-the-Counter Product Litigation and Expediting the Drug Approval Process.

Publication Date: August 2023
ISBN: 978-1-4024-4340-4
Page Count: 946 pages
Number of Volumes: 1

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