Federal Register notice: FDA makes available a draft document entitled Food and Drug Administrations Draft Report and Plan on Best Practices for Guida...
FDA says it is evaluating the need for regulatory action after seeing a safety signal for some additional side effects in GLP-1 receptor agonists like...
FDA clears a Siemens Healthineers 510(k) for the MAGNETOM Cima.X 3 Tesla (3T) magnetic resonance imaging whole-body scanner.
FDA removes a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous and peripheral T-cel...
PhRMA says FDA should consolidate its recent draft guidance on Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bioresearch Monitoring F...
A European Medicines Agency committee has approved the International Council on Harmonizations Guidelines on viral safety evaluation of certain produc...
Eagle Hill consultants say FDA can profit from greater use of cloud technology if it can overcome some obstacles the consultants identified.
FDA cancer researchers say the Oncology Center of Excellence is working with stakeholders to simplify cancer clinical trials when appropriate.
