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    FDA pilot program to offer technical guidance, additional clarity on approval pathways as a way to shorten drug development time, better compete with China
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    The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "General Considerations for the Use of New Approach Methodologies in Drug Development " The purpose of this draft guidance is to provide drug developers with a validation
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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 Food and Drug Administration on Monday announced a series of initiatives aimed at accelerating clinical trials and modernizing drug development, part of a broader effort to reduce delays in
  • FDA launches clinical trial reforms to counter China threat
    The Food and Drug Administration (FDA) on Monday launched a new initiative to speed up early-stage clinical trials as part of an effort to reduce development timelines and reverse a growing trend o…
  • 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    The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was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





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