The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...
Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
The US Food and Drug Administration (FDA) has published draft guidance for applicants for new drug applications (NDAs) and ...
The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...
The FDA’s press release noted that the guidance supports development of an array of cell and gene therapy products, including ...
Opinion: In response to the FDA's updated cybersecurity guidance on medical devices, manufacturers should follow "secure by design" principles, ensure cyber transparency, conduct threat modeling, and ...
FDA revises 2022 human factors guidance with new risk-based categories, device modification examples, and 60-day ...
The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs. “This draft guidance not only ...
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.
Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...
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