News Updates
- Benefits of Integrating Patient Engagement with Diversity, Equity, and Inclusion in New Medical Product Development: A Call for Action
- Drug Shortages in the Global South: A Proposed Parallel Tech and Reg Transfer Framework
- Fair Pay for Patient Engagement: Navigating the Evolving Landscape of Remuneration
- Industry’s Window to Express Interest in Africa Continental Product Evaluation Pilot Closes End of February 2024
- The Importance of Regulatory Due Diligence During the Acquisition Process
The Impact of Innovation - How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework
Abstract
Rapid advances in technology and our understanding of disease will lead to a shift in how the health care system thinks about data, which will in turn challenge current regulatory constructs. In the future, there will be a shift away from milestone-based data to continuous, contextual data; we believe this data shift will impact the current model of medical product regulation, with potential implications across the regulatory landscape, reflecting the convergence of clinical development and clinical practice.