CDER says its scientists are investigating how to improve pediatric dose selection by predicting drug clearance from renal function equations.
Two Hyman, Phelps medical device technical experts review provisions in a new FDA draft guidance on medical device software premarket submissions.
The House Select Committee on Covid-19 asks former FDA commissioner Stephen Hahn for documents and an interview on Trump administration efforts to inj...
FDA grants Isofol Medical a fast track designation for arfolitixorin, a stabilized and biologically active pure form of folate ([6R]-MTHF) for treatin...
New financial disclosure documents show Robert Califf earned millions of dollars last year from industry, which could disrupt the confirmation process...
Four Sidley attorneys see significant regulatory change in a new FDA draft guidance on benefit/risk expectations for drug development, and they urge i...
Federal Register notice: FDA issues a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagn...
Federal Register notice: FDA issues a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative de...