The U.S. FDA's Drug Information is on Trial

A recent court decision in the United States raises questions about the Food and Drug Administration's (FDA) ability to advise the public about the safety and efficacy of medical products and to influence the off-label use of drugs.

The complete, unedited article Perspective, written by Tina Watson, B.A. and Christopher Robertson, J.D., Ph.D., was published by the New England Journal of Medicine on December 16, 2023.

Vaccines, as with all products regulated by the FDA, undergo a rigorous laboratory and clinical data review.

Vaccines approved for marketing in the U.S. may also require additional studies to evaluate the immunization further and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects.

General and specific vaccine information can be found in the following FDA link.