Attorney Jeffrey Shapiro says the administration executive order on regulations may encourage FDA to issue Medical Device Reporting changes that Congr...
Three Mayer-Brown attorneys analyze a recent FDA draft guidance on biosimilar interchangeability.
During his address to Congress, president Trump takes aim at speeding up FDAs approval process and cutting regulations.
FDA approves a CeloNova BioSciences PMA for its first-in-class Cobra PzF NanoCoated Coronary Stent System.
Rep. Gus Bilirakis introduces legislation to provide incentives for drug makers to repurpose mainstream treatments for rare diseases.
Duane Morris attorneys explain provisions in an FDA draft guidance on generic drug 180-day marketing exclusivity.
CDRH cautions healthcare providers to be aware that using a neurovascular guide catheter for an off-label indication of thrombus removal could affect ...
FDA approves a Lexicon Pharmaceuticals NDA for Xermelo (telotristat ethyl) tablets in combination with somatostatin analog therapy for treating adults...