The U.S. Food and Drug Administration (FDA) is weighing a change that could make warning labels on dietary supplements appear less often on packaging. Unlike prescription drugs, dietary supplements ...

Supplements are not reviewed by the U.S. Food and Drug Administration before they are sold The FDA may allow warning labels to appear just once per package rather than after every health claim Some ...

To wrap up an already complicated 2025 for medtech, FDA has lost two major leaders in the digital and medical device space. According to sources, Jessica Paulsen, acting deputy director of FDA’s ...

The FDA approved a label change for Pfizer’s birth control injection Depo-Provera on Dec. 13, adding a warning about the risk of meningioma — a brain tumor — to two versions of the drug. The update ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...

The Food and Drug Administration is considering a rule change that would cut back on how often dietary supplement warnings must appear on packaging, a move experts say could make them easier to miss.

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...

The U.S. Food and Drug Administration is reportedly weighing whether it will place a “black box” warning label on COVID vaccines, according to CNN, despite research and real-world data demonstrating ...

Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and ...