[ Price : $8.95]
FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational p...[ Price : $8.95]
CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the D...[ Price : $8.95]
FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical pr...[ Price : $8.95]
FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combinati...[ Price : $8.95]
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Su...[ Price : $8.95]
FDA issues Rocket Pharmaceuticals a complete response letter on its BLA for gene therapy Kresladi (marnetegragene autotemcel; marn...[ Price : $8.95]
FDA approves a Shorla Oncology NDA for Tepylute (thiotepa), a ready-to-dilute formulation for treating breast and ovarian cancer.