FDA issues a warning against using Dr. Bernes MSM Drops 5% Solution and LightEyez MSM Eye Drops Eye Repair due to bacterial or fungal contamination....
Federal Register notice: FDA extends the comment period for a 7/14 notice that announced the availability of a draft guidance entitled Manufacturing C...
Federal Register notice: FDA announces an 11/29-30 public workshop entitled Workshop to Enhance Clinical Study Diversity.
Draeger Medical recalls its Carina Sub-Acute Care Ventilators due to the presence of contaminants in the devices airpath.
Rep. Debbie Dingell asks FDA and CDC to answer questions about recent cases of tuberculosis linked to contaminated Aziyo Biologics bone grafts.
Three stakeholders make suggestions to an FDA draft guidance on efficacy endpoints in clinical trials for antidiabetic drugs.
Lilly says its Retevmo met the primary progression-free survival endpoint in a clinical trial in patients with RET-mutant medullary thyroid cancer.
FDA clears a Welldoc 510(k) for its BlueStar diabetes digital health device that provides bolus insulin dose recommendations based on readings from co...
