Press Release (ePRNews.com) - Toronto, Canada - Jan 23, 2018 - In this first of a two-part series taking place on Thursday, February 8, 2018, featured speakers from PinneyAssociates Christine Sweeney, Ph.D., MPH, Director of Issues Management and George Quesnelle, Senior Strategic Advisor of OTC Commercialization and Optimization will focus on best practices for achieving regulatory approval of an Rx-to-OTC switch.
Rx-to-OTC switch is a complex process involving numerous parallel workstreams; the goal of the process is regulatory approval of a commercially viable OTC product that will benefit public health.
The presenters will flag the critical points in the regulatory process where commercial teams need to become involved, although the best practices for achieving commercial success will be covered in further detail in the second webinar of the series.
Successful Rx-to-OTC switches have been defined by:
- Thoughtful selection of switch candidates through regulatory and commercial feasibility assessments
- Early development of FDA strategy, taking into consideration development of a sound Drug Facts Label and other consumer information materials, as well as well-designed consumer studies. These studies include label comprehension, self-selection and, if needed, behavioral (actual use) data to demonstrate the drug can be used safely and effectively in the nonprescription setting
- Identifying and addressing concerns of FDA and other key stakeholders with science-based, data-driven responses
- Building a compelling benefit/risk case for the switch
- Strong leadership and project management linking regulatory, clinical, medical and commercial strategies and workstreams
For more information about this complimentary webinar, visit: Rx to OTC Switch: Planning for Regulatory Success
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Nima Rajan Source :
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