Early Drug Research To Become Easier In the U.S.

 

 

“Drug companies have increasingly been doing early research in countries like China and Australia where they say it takes less time and money. U.S. officials are taking new steps to keep those studies at home.

 

Federal health officials unveiled a package of regulatory reforms on Monday with the aim of cutting about six months to a year off the time it takes to do a safety study, which is the first round of testing drugs in people. The move comes as drug companies are actively buying Chinese biotechs, often citing the speed of the country's regulators.

 

To help bring investment back into the U.S., the Food and Drug Administration plans to offer companies more clarity about what manufacturing information they should submit in early research phases, how to go about finding the correct dose for patients and a rolling review that allows an application to be evaluated before completion.

 

The agency will also launch a pilot program designed to speed up early trials, officials said, though the program is still in development.

 

The agency also reaffirmed a new policy, first made under former commissioner Marty Makary, that one high-quality clinical trial showing a drug works, plus safety evidence and follow-up confirmation, is enough to earn FDA approval for a treatment, versus the two previously expected.

 

"We've been witness to a growing share of phase one clinical trials moving overseas," acting FDA commissioner Kyle Diamantas said.

 

As part of the government's efforts, the National Institutes of Health plans to examine how to speed up clinical trials in the U.S. using new trial designs, artificial intelligence, real-world data and other tools, said NIH director Jay Bhattacharya.” [1]

 

1. U.S. News: Early Drug Research To Become Easier In the U.S. Whyte, Liz Essley; Martinez, Xavier.  Wall Street Journal, Eastern edition; New York, N.Y.. 23 June 2026: A3.