FDA launches expedited IND pilot program, integrating public feedback into qualification criteria

The FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday.

Agency leaders Karim Mikhail and Michael Davis, newly appointed permanent directors, said the pilot incorporates feedback received from the public to shape the eligibility criteria for participating sponsors.

The move is intended to speed the development of promising therapies while ensuring that the program reflects stakeholder input, marking a significant step in the FDA’s effort to modernize the drug-development process.