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Four Sidley attorneys see significant regulatory change in a new FDA draft guidance on benefit/risk expectations for drug development, and they urge i...
FDA says it is making progress in the backlog of inspectional work needed to render review decisions on outstanding medical product applications that ...
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...
Federal Register notice: FDA issues a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for...
Federal Register notice: FDA extends the comment period for a 9/24 over-the-counter monograph proposed order until 12/27.
FDA accepts for priority review a bluebird bio BLA for betibeglogene autotemcel, a gene therapy for patients with β-thalassemia across all genoty...