Federal Register notice: FDA announces a 5/2 annual meeting of the Reagan-Udall Foundation that will discuss its activities and how they support FDA.
The Washington Post reports that Gilead Sciences is fighting to prevent the U.S. government from reaping any financial benefit from CDC's discovery of...
FDA is watching the Supreme Court to see if it will change the so-called Auer standard calling for courts to grant deference to federal agency interpr...
FDA clears a MiRus 510(k) for the MoRe-based Europa Pedicle Screw System, which the company says is the first cleared medical device with this new cla...
FDA warns the iMedDo Web site that it is selling unapproved and misbranded human and animal drugs.
FDA approves a Clarus Therapeutics NDA for Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogon...
FDA clears an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia...
FDA proposes its first amendments to mammography facility regulations in over 20 years.