New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints
Description:
A letter report issued by the Government Accountability Office with an abstract that begins "Before approving a drug, the Food and Drug Administration (FDA) assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint--a laboratory measure, such as blood pressure--instead of more direct clinical evidence, like preventing strokes. After approval, FDA often requires or requests a drug sponsor to further study the drug.…
more
Date:
September 23, 2009
Creator:
United States. Government Accountability Office.
Partner:
UNT Libraries Government Documents Department