FDA issues a warning against Miracle Mineral Solution because it is illegally promoted as a remedy for treating autism, cancer, HIV/AIDS, hepatitis an...
A group of U.S. Senate Democrats urge FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting manipulated data in its BLA for re...
FDA clears a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic table system.
Federal Register notice: FDA extends the comment period on a 7/9 notice about a public meeting alternative clinical trial approaches for new animal dr...
FDA grants Dare Bioscience a qualified infectious disease product designation for its bacterial vaginosis therapy.
Fresenius Kabi recalls its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to alarm and multiple software errors.
FDA Review posts the Federal Register notices for the week ending 8/9/2019.