B. Braun asks FDA to assign AP therapeutic equivalence codes to some of its injectable products in the Orange Book.
FDA clears an Ossio 510(k) for its OssioFiber Hammertoe Fixation System for maintenance of alignment and fixation of bone fractures, osteotomies, arth...
FDA issues a safety alert on potential infection risk from using fecal microbiota for transplantation to treat C. difficile infections.
Alston & Bird reviews provisions in FDAs announcement postponing foreign inspections and offers guidance to regulated industry.
FDA grants Boehringer Ingelheim and Eli Lilly a fast track designation for Jardiance (empagliflozin) and its use to reduce the risk of kidney disease ...
A day after FDA commissioner Stephen Hahn was criticized during a 3/11 hearing about delays in testing amid the coronavirus outbreak, National Institu...
FDA releases the FDA-483 with five observations from an inspection at Indias Biocon Limited API manufacturer.
FDA issues a guidance on its implementation of the 510(k) third party review program.