FDA revises a guidance and withdraws a Compliance Guide to clarify its risk-based approach to regulatory enforcement of homeopathic drug products.
FDA approves an Allergan supplemental BLA for Botox in treating pediatric patients (two to 17 years of age) with lower limb spasticity, excluding spas...
Federal Register notice: FDA sends to OMB an information collection extension for Data to Support Social and Behavioral Research as Used by the Food a...
FDA approves a Flowonix Medical PMA to market the Prometra II 40 mL Programmable Infusion Pump and its associated programmer software.
An FDA safety alert warns that CholesLo, a product promoted and sold for lowering cholesterol on various Web sites contains an undeclared drug ingredi...
The Washington Post says President Trump is ready to name MD Anderson Cancer Center chief operating officer Stephen Hahn to be FDA commissioner.
FDA grants Fresenius Medical Care a breakthrough device designation for its new hemodialysis system that aims to prevent blood clotting without the us...
FDA calls for a breast implant Boxed Warning and other labeling changes to help ensure that patients have information needed to make an informed decis...