The pharmaceutical industry is under increasing scrutiny arising from alleged misconduct in its development and commercialization activities. Government investigations alleging violations of the False Claims Act for failure to comply with provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), particularly relating to off-label promotion of drug products, have resulted in record fines and imposition of restrictive Corporate Integrity Agreements (CIAs).
This environment places greater emphasis on the regulatory function within companies to provide expertise and oversight to all aspects of the drug development and marketing process. This RAPS Webcast will review and analyze the regulatory issues addressed in recent CIAs, provide an understanding of how regulatory practice will play a critical role in identifying potential regulatory violations and identify processes to minimize compliance-related risks targeted by regulators.