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The agency reviewed the company’s websites on June 21 and found that the products were still being marketed without FDA approval, clearance or authorization. Read More
The company plans to market its BD Onclarity HPV assay to high-throughput labs that process a majority of cervical cancer screening specimens in the U.S. Read More
Australia’s Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) urged regulators to consider taking a risk-based approach to the use of artificial intelligence (AI) in the pharmaceutical industry in a new report. Read More