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America Must Address Early Clinical Development
Developing
In Short: The FDA is hosting a webinar to discuss a new pilot program aimed at accelerating the transition from drug discovery to first-in-human clinical trials, enhancing the U.S.'s position in pharmaceutical innovation.
The Food and Drug Administration (FDA) is launching an educational webinar to introduce a new Expedited Investigational New Drug (IND) pilot program, designed to expedite the process from drug identification to the first-in-human (FIH) clinical trial.
This initiative is part of broader efforts 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 U.S. as the global leader in pharmaceutical innovation and regulatory standards, with the new pilot program focusing on leveraging the nation's top research institutions as collaborative partners.
The proposed pilot program seeks to shorten the timeline from drug discovery to FIH studies, ensuring the safety and well-being of clinical trial participants while maintaining rigorous regulatory standards.
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