Overview
By analyzing the foundations of pharmaceutical industry regulation and current legal, regulatory, and compliance developments, the new Tenth 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 individually and collectively constitute the enforcement environment.
Highlights of the new edition include updated chapters on:
- 483s and Warning Letters;
- Regulation and Compliance for Dissemination of Medical Information;
- Government Oversight of Off-Label Promotion and Dissemination of Scientific Information;
- Risk Evaluation and Mitigation Strategies (REMS) and Related Post-Market Safety Oversight;
- Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure for Pharmaceutical Manufacturers;
- Criminal Prosecution of the Federal Food, Drug, and Cosmetic Act and Related Statutes;
- The False Claims Act and Enforcement Against Pharmaceutical Manufacturers; and
- The Foreign Corrupt Practices Act and Its Impact on the Pharmaceutical Industry.
Publication Date: September 2024
ISBN: 978-1-4024-4604-7
Page Count: 962 pages
Number of Volumes: 1
Topics
Regulation and compliance (Communications and telecommunications)
Regulation and compliance (Corporate law)
Health care
Enforcement (Health care)
Regulation and compliance (International law)
Enforcement (Life sciences)
Practice skills (Life sciences)
Pharmaceuticals
Regulation and compliance (Life sciences)
Enforcement (Securities and other financial products)
Regulation and compliance (Securities and other financial products)