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- 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
Perspectives on FDA’s Accelerated Approval Program
While it is clear that FDA and drug sponsors must work together to proactively plan and diligently implement clinical trials for the collection of data sufficient to “convert” accelerated approval into traditional approval, equally important is ensuring that while clinical trials are pending, patients who receive AAP-approved drugs in the clinical setting fully understand the program, its limitations, and the tradeoffs they are making.
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