The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

The FDA’s press release noted that the guidance supports development of an array of cell and gene therapy products, including ...

The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are ...

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...

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 ...

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 ...

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.