Abstrakt: |
The Freedom of Information Act mandates that Federal agencies provide access to their files to any individual requesting information. Files available from the Food and Drug Administration are particularly valuable to medical librarians, offering information about the approval and regulation of medical devices and pharmaceuticals. This article briefly describes the approval process for drugs and devices and the corresponding records that generally are held on file at the Food and Drug Administration. Instructions for structuring a Freedom of Information Act request letter, resulting charges, and expected responses are outlined. [ABSTRACT FROM PUBLISHER] |