FDA Actions to Accelerate and Modernize Clinical Drug Development Today, the FDA is announcing actions to accelerate and modernize clinical research across the full continuum of drug development —from the pre-Investigational New Drug (IND) phase to late-stage pivotal trials The agency is eliminating unnecessary regulatory burden, clarifying phase-appropriate requirements and building partnerships with government, academic medical centers and the private
US FDA updates guidance to speed up drug development - MSN June 22 (Reuters) - The U S Food and Drug Administration said on Monday it is launching a series of measures to speed up drug research, from early-stage investigational studies to late-stage
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US FDA updates guidance to speed up drug development 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
FDA revises master protocol guidance with new section on basket trials The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was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