FDA Unveils Framework for Its Expedited IND Pilot

FDA unveils framework for its expedited IND pilot

The FDA has published the design of its expedited Investigational New Drug pilot, part of a plan to restore US competitiveness in clinical 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.

FDA launches pilot program to speed up sluggish phase 1 trials

Darren Incorvaia in Fierce Biotech: After teasing a new initiative to speed up early-stage clinical trials over the summer, the FDA today opened a pilot program for an expedited investigational new drug (IND) application process that the agency hopes will put U.S. phase 1 trials on par with those in China and Australia. The finalized pilot program will pair drug sponsors with selected “qualified research institutions” or QRIs, which can include …