(Reuters) -The U.S. Food and Drug Administration on Wednesday classified a recall of Hologic’s devices that are implanted in soft tissue such as breast tissue as […]
Summary of Proceedings FDA virtually convened its 12th intergovernmental working meeting on drug compounding with state government officials on November 7 and 8, 2023. Attendees included […]
TOPLINE: A DNA methylation signature outperformed a clinical model at identifying individuals with type 1 diabetes (T1D) who risked progressing to end-stage kidney disease. METHODOLOGY: Researchers […]
Many serious patient illnesses and deaths linked to poor quality compounded drugs have occurred since the 2012 fungal meningitis outbreak. In response, FDA has established an […]
Summary Company Announcement Date: May 21, 2024 FDA Publish Date: May 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]
Contains Nonbinding Recommendations Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? Assuming each […]
New findings challenge the practice of rapidly lowering blood pressure (BP) in acute ischemic stroke to allow for speedy thrombolysis. The observational cluster study showed that […]
BASEL, SWITZERLAND — Minor ischemic stroke patients with intracranial occlusion should not be treated with IV thrombolysis, a new trial has concluded. Results from the randomized […]
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