This report was first published by Endpoints News. To see the original version, click here
The White House threw its weight behind efforts to help US biotech compete with China, using the administration’s budget proposal to outline FDA policy changes to speed up trials, cut costs for companies that do experimental work in the US, and expedite regulatory reviews.
One of the reforms is a new clinical trial pathway that reflects the quicker processes other countries have. The expedited pathway would be for some Phase 1 trials where there are enough existing preclinical data to satisfy regulators. The FDA specifically expects the pathway to help “smaller biotechnology firms,” saying that the US’ existing IND process has fueled growth in China and Australia.