Overview
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.