The CDER Office of Prescription Drug Promotion wants to conduct research into how consumers and primary care doctors define and interpret 30 terms oft...
FDA clears a de novo marketing request from Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay for detecting human immunodeficiency virus Ty...
Three stakeholders recommend improvements to an FDA draft guidance on testing and labeling medical devices for safety in the magnetic resonance enviro...
FDA says a Medtronic recall of its MiniMed insulin pumps due to potential cybersecurity risks is Class 1.
Sens. Warren and Murray raises objections to and questions about an FDA proposal for a progressive approval pathway for medical devices.
FDA releases its latest batch of Warning Letters that includes one medical product company Bingbing Pharmaceutical.
Philips Medical Systems recalls (Class 1) the Forte Gamma Camera System due to a nonconforming material/component.
FDA approves a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules for treating Helicobacter ...