America Must Address Early Clinical Development

Aug 5 ETDeveloping

Health Desk

In Short: The FDA is launching an educational webinar on a new Expedited Investigational New Drug (IND) pilot program aimed at accelerating drug development from identification to first-in-human trials.

Clinical development of TRPV1 antagonists — Photo: Hopur2-2009 / Wikimedia Commons (CC BY-SA 3.0)

The Food and Drug Administration (FDA) is announcing an educational webinar on a proposal to establish the Expedited Investigational New Drug (IND) pilot program, designed to expedite the time from drug identification to first-in-human (FIH) clinical trials.

This initiative is part of a broader effort by the FDA to accelerate and modernize clinical research across the full continuum of drug development, from early identification to late-stage trials.

The FDA aims to ensure the United States remains the global standard for pharmaceutical innovation and regulatory rigor, benefiting both American patients and innovators.

The proposed Expedited IND pilot program seeks to leverage America’s world-class research institutions as collaborative partners to shorten the time from drug identification to first-in-human study, all while maintaining 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