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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.
Chapter 1 The Importance of Rx-to-OTC Switch to Consumer Self-Care Chapter 2 Why Switch? Evaluating the Value of Switch Candidates Chapter 3 What is the Rx-to-OTC switch process in the US and how does FDA regulate switches Chapter 4 Plan B Case Study: A Story of Politics Over Science Chapter 5 Prilosec OTC: A Case Study Chapter 6 The History and Future of Rx-to-OTC Switch for Lipid Management in the US Chapter 7 Review of the Rx-to-OTC Switch of Oxytrol for Women Chapter 8 Differin Gel OTC Switch: Bringing Innovation to a Well-Established Category Chapter 9 Intranasal Corticosteroids for Allergy OTC Switch: A US Case Study Chapter 10 EU and RoW Switches Chapter 11 Conclusion
The availability of OTC medicine provides significant value to the US healthcare system relative to prescription alternatives. The market is expected to grow exponentially over the next several years creating new commercial opportunities for pharmaceutical manufacturers and exposing a need for an easy to understand, practical resource for regulatory professionals who need to plan, manage, and execute a successful switch program.
Through a series of case studies, Lifecycle Management Through the Rx-to-OTC Switch will guide readers through the basic requirements for implementing a switch to increase availability of, access to, and adoption of OTC medications. This comprehensive manual is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.