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    Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials
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  • FDA Launches New Pilot to Speed Early-Stage Drug Development
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    The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was proposed Among the updates is a new section on evaluating drug effects across multiple diseases, conditions, or disease subtypes in basket trials
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    US FDA updates guidance to speed up drug development The FDA said it is planning a new pilot program that would pair drug sponsors with qualified research institutions such as academic medical centers and contract research organizations ⁠to shorten the ‌time from drug identification to first-in-human studies
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    The “Single Pivotal Trial” Shift: For later-stage drug development, the FDA issued revised draft guidance signaling a newfound openness to granting drug approvals based on a single, highly rigorous Phase 3 pivotal trial paired with strong confirmatory evidence, rather than strictly requiring the traditional standard of duplicate large-scale





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