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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Part I: Fundamentals
Chapter 1 Introduction to the Agencies Involved in Prescription Drug and Device Labeling
Chapter 2 Fundamental Principles for Labeling and Promotion of Prescription Medical Products
Chapter 3 Labeling and Promotion of Regulated Products Prior to Approval and Off-Label Promotion
Part II: Communications to Certain Audiences
Chapter 4 Promotion to Healthcare Professionals and Providers
Chapter 5 Direct Promotion of Prescription Products to Consumers and Patient Populations
Chapter 6 Promotion to Payers and Other Sophisticated Audiences
Part III: Practical Advice for Regulatory Professionals
Chapter 7 Additional Regulatory and Legal Considerations
Appendix 1. Selected Sections of the FD&C Act
Appendix 2. Selected FD&C Act Regulations
Appendix 3. List of Available Guidances Regarding the Labeling, Advertising and Promotion of Prescription Drugs