FDA Says Mpox Drugs Not Exempt From Human Testing Under Animal Rule

By Lia DeGroot / January 20, 2023 at 3:22 PM
In a draft guidance published Thursday (Jan. 19), FDA makes clear that mpox drugs and biological products must be tested in human clinical trials in order to garner approval, which differs from how the agency has handled testing for smallpox therapeutics, including those that are currently used for mpox. The draft guide does not apply to preventive vaccines, since those products raise different questions around subject selection, safety monitoring and effectiveness evaluation. FDA says vaccine developers should contact the agency’s...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.