FDA clears a Bioness 510(k) for the L300 Go System, intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and assis...
The Federal Trade Commission says Shire ViroPharma flooded FDA with petitions and court suits over generic Vancocin capsules as a means to delay agenc...
Arent Fox attorneys caution that implementation of provisions of the 21st Century Cures Act requiring new regulations may be delayed by a Trump admini...
Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) write the White House Office of Management and Budget asking for additional guidance clarifying wheth...
Federal Register Notice: FDA delays until 3/21 the effective date of its final rule amending the regulations regarding intended uses while being scrut...
Drug company executives prefer former FDA deputy commissioner Scott Gottlieb as the candidate president Donald Trump should nominate for commissioner,...
FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) injection, for intravenous use for treating patients with locally advanced or metastatic urothel...
The LA Times reports that many FDA watchers fear patients could be exposed to ineffective therapies if president Trump appoints a commissioner who wou...