As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

From turning away inspectors to falsifying data and leaving "bare footprints" in production containers, two of the latest ...

Ensure your FDA inspection readiness with expert guidance! Learn how to navigate audits, maintain compliance, and implement effective CAPA strategies.

JERUSALEM (AP) — In the Shuafat refugee camp, a hardscrabble district in east Jerusalem surrounded by a concrete wall, cars inched their way toward an Israeli checkpoint. Intense security makes ...

The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

Broccoli florets sold in Walmart stores across 20 states that were recalled over bacterial contamination fears have been given the U.S. Food and Drug Administration (FDA)'s highest risk level.

An audit released by the Inspector General of the U.S. Department of Health and Human Services, the parent organization of the Food and Drug Administration (FDA), is not a pleasant read. Let us turn ...

It’s not clear if the changes are temporary or if the pages will be restored. When asked about the removed webpages, an FDA spokesperson directed MedTech Dive to contact the Department of Health and ...

Red 3 – also called FD&C Red No. 3, erythrosine or E127 – has been widely used in food, cosmetics and pharmaceuticals since its FDA approval in 1969. You’ve likely encountered Red 3 before.

As of the FDA's last update on Jan. 15, authorities were investigating multiple outbreaks of E. coli and Listeria. Publication of the Centers for Disease Control and Prevention's authoritative ...

In the FDA’s authorization announcement, the agency said it will closely monitor the marketing and use of these products. “We don’t want to see young people taking up nicotine in any form ...