Explore the FDA’s 2025 Human Foods Program Guidance Agenda and what it means for US food and beverage businesses. Key ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

The FDA’s new draft guidance comes on the heels of a reflection paper from the European Medicines Agency on the use of AI in the drug product lifecycle, finalized in September 2024.

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device ...

The FDA noted that a key principle in developing guidance for early AD therapies is that treatment "must begin before there are overt clinical symptoms." "We enthusiastically support this idea ...

The Guidance applies to drug manufacturers and applicants and to a broad range of products, including those marketed under approved New Drug Applications, Abbreviated New Drug Applications, over ...

For the first time in history, the U.S. Food and Drug Administration has established guidance for levels of lead in processed baby foods that are sold on supermarket shelves and online. The agency ...

For the first time in history, the U.S. Food and Drug Administration has established guidance for levels of lead in processed baby foods that are sold on supermarket shelves and online. The agency ...

FDA sets new lead level guidelines for baby foods Share Updated: 2:00 PM EST Jan 6, 2025 Infinite Scroll Enabled ...

For the first time in history, the U.S. Food and Drug Administration has established guidance for levels of lead in processed baby foods that are sold on supermarket shelves and online. The agency ...