The FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic are “a really good first step in ensuring that clinical trials continue with minimum disruption,” according to Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP).
The U.S. FDA issued a new draft guidance for drugmakers aiming their resources at Fabry disease, a rare genetic disease.
The U.S. Food and Drug Administration issued a draft guidance on improving the diversity of patient populations in clinical trials.
“We have been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development,” says FDA Commissioner Scott Gottlieb, M.D.
The FDA issued draft guidance for biopharma companies on developing therapies for NASH with liver fibrosis.
In a new draft guidance, the U.S. FDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary.
The U.S. Food and Drug Administration issued a new draft guidance for the development of novel medicines aimed at the treatment of opioid use disorder.
The U.S. Food and Drug Administration withdrew the regulatory agency’s draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.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.
“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. …”