FDA Launches Pilot Program to Speed up Early US Drug Research

FDA takes applications for new program to shorten drug approval times

The Food and Drug Administration pilot aims to help companies move more quickly to testing their products in humans.

FDA launches pilot program to speed up early US drug research

First teased in June and formally announced Tuesday as part of “Operation Trialblazer,” the program will partner drugmakers with research institutions to more quickly bring drugs into human testing. 

FDA Unveils Pilot Program Aimed at Accelerating Early-Stage Clinical Trials

As reported on Fierce Biotech, the U.S. Food and Drug Administration (FDA) has launched a new pilot program designed to streamline the investigational new drug (IND) application process and reduce delays that often slow the start of Phase 1 clinical trials. The initiative is part of the agency’s broader effort to strengthen the United States’ […]

FDA Launches Expedited IND Pilot Program

This FDA Expedited IND Pilot QRI program pairs up to 10 sponsors with research institutions for rolling review.

Breakthroughs in Hard Endpoints for Kidney Disease Therapies, FDA Expedited IND Pilot, and GSK Trispecific Antibody Licensing

Vera IgAN trial hard endpoints, FDA Expedited IND Pilot, GSK $750M trispecific deal, Ori Biotech CGT automation, & Legend Biotech CEO.

FDA Launches Expedited IND Pilot to Speed Up Clinical Trials

The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot. Accelerating clinical trial timelines and eliminating regulatory hurdles to maintain American leadership in global medical innovation is a core priority for the Trump Administration.