On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

A seasoned FDA compliance and regulations expert says you can watch for these major ways health intelligence may change for ...

“There's a whole ton of questions about, well, am I subject to regulation or not?” Faget said. “FDA issued guidance on this issue, which is about as clear as mud, to be honest, and I have ...

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in ...

Nasal vaccine devices have the potential to offer more convenient and more effective protection against a variety of viruses.

The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or explanation.

and served on the FDA Drug Safety and Risk Management Advisory Committee from 2017 to 2024. These guidelines were established under the Food and Drug Omnibus Reform Act of 2022, enacted by ...

FDA considers the following action levels to be achievable by the food industry when control measures are taken to minimize the presence of lead.

Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st ...