FDA asks for answers to several questions about factors that should be considered in requests from sponsors of drugs subject to REMS related to change...
The International Council for Harmonization releases for public comment a draft document entitled ICH Harmonized Guideline Good Clinical Practice (GC...
FDA asks for proposals to develop artificial intelligence systems to assist it with drug product imaging and analysis.
The Digital Medicine Society praises FDA for its work in addressing using digital health technologies in drug and biological product development.
FDA warns Gujarat, India-based Champaklal Maganlal Homeo Pharmacy Private Limited and two New Castle, DE-based companies that they are distributing tw...
SD Biosensor recalls its Pilot Covid-19 At-Home Test due to microbial contamination.
A University of Florida law professor calls on FDA to define personal injury attorney client-seeking ads that cross a line and may harm patients using...
