The FDA issued draft guidance for biopharma companies on developing therapies for NASH with liver fibrosis.
In a new draft guidance, the U.S. FDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary.
The U.S. Food and Drug Administration issued a new draft guidance for the development of novel medicines aimed at the treatment of opioid use disorder.
The U.S. Food and Drug Administration withdrew the regulatory agency’s draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.
U.S. regulators proposed lowering the bar for clinical trial success for experimental Alzheimer’s drugs.
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse
“As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. …”
The U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.