Rx-to-OTC switch
YOUR NEEDS
- Make a well-informed go/no-go decision based on an evaluation of a drug’s regulatory and commercial Rx-to-OTC switch potential
- Demonstrate in well-designed consumer studies that consumers can follow the Drug Facts Label and use a drug safely and effectively in the nonprescription setting
- Compellingly address the concerns of FDA and other stakeholders
- Gain regulatory approval and maximize product success
OUR SERVICES
- Assess the feasibility of regulatory and commercial success of a switch based on a comprehensive assessment of the science and the issues likely to be raised by the switch
- Develop and help execute an FDA strategy in support of IND and NDA submissions
- Draft and evaluate OTC Drug Facts Labels, Consumer Information Leaflets, and behavioral support materials
- Plan and help design the overall development program, including label comprehension studies, self-selection studies, actual use trials and tailored consumer studies
- Identify data needs and develop specialized research to support product approval and marketing claims
- Build the benefit/risk case and develop a compelling science-based public health rationale for the switch
- Assist in development of post-marketing commitments
OUR EXPERTISE
- Clinical and Behavioral Research
- Data Management and Statistical Analysis
- Clinical Pharmacology
- Regulatory and Health Policy
- Integrated Strategic Communications
Value to our clients
PinneyAssociates understands that Rx-to-OTC switches are complex initiatives that raise regulatory, scientific/medical, policy and commercial issues involving sometimes conflicting interests of multiple stakeholders. We have over 20 years of experience in providing strategic regulatory insights for OTC switches, direct-to-OTC approvals, and existing OTC products, which enables us to provide comprehensive science-based support to sponsors throughout the product lifecycle.