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America Must Address Early Clinical Development
Developing
In Short: The FDA is introducing an Expedited Investigational New Drug (IND) pilot program to accelerate the process from drug identification to first-in-human clinical trials, aiming to maintain the U.S. as a global leader in pharmaceutical innovation.
The U.S. Food and Drug Administration (FDA) is launching an educational webinar on a new proposal to establish the Expedited Investigational New Drug (IND) pilot program, designed to expedite the timeline from drug identification to first-in-human (FIH) clinical trials.
This initiative is part of a broader effort by the FDA to modernize and accelerate clinical research across all stages of drug development, from initial identification to late-stage pivotal trials.
The FDA emphasizes its commitment to maintaining the United States as the global standard for pharmaceutical innovation and regulatory rigor, with the goal of benefiting both American patients and pharmaceutical innovators.
The proposed Expedited IND pilot program aims to shorten the time from drug identification to the first-in-human study by leveraging the expertise of America’s leading research institutions as collaborative partners, all while ensuring the safety and rights of clinical trial participants.
What's confirmed
What's still developing
- ET The FDA is announcing an educational webinar on a proposal to establish the Expedited Investigational New Drug (IND) pilot program, a new program meant to accelerate the time from drug identification to…
- Food and Drug Administration (FDA) is announcing actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage…
- The FDA is committed to ensuring the United States remains the global standard for pharmaceutical innovation and regulatory rigor for the benefit of American patients and innovators.
- Expedited Investigational New Drug Pilot Program Request for Information The proposed Expedited IND pilot program would leverage America’s world-class research institutions as collaborative partners to shorten the…
Sources
- fda.govlink