Concerns that political pressure could undermine the U.S. drug approval system intensify this week after a new White House directive on psychedelic therapies appears to be steering FDA toward accelerated reviews that could damage scientific integrity.
FDA plans to unveil a significant shift in how clinical trials are conducted and regulated, announcing “major steps to implement real-time clinical trials.”
Concerns that political pressure could undermine the U.S. drug approval system intensify this week after a new White House directive on psychedelic therapies appears to be steering FDA toward accelerated reviews that could damage scientific integrity.
FDA plans to unveil a significant shift in how clinical trials are conducted and regulated, announcing “major steps to implement real-time clinical trials.”
A federal judge dismisses a lawsuit brought by homeopathy advocates and a product distributor challenging FDA’s decision to tighten oversight of homeopathic drugs.
Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treatment for hereditary angioedema.
