United States of America. The Food and Drug Administration has issued new regulations on the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases in order to clarify existing regulations under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. The regulations include a definition of diagnostic radiopharmaceuticals and provisions that address the following aspects of these products: (1) General factors to be considered in determining safety and effectiveness; (2) proposed indications for use; (3) evaluation of effectiveness; and (4) evaluation of safety.
The full text is available on request.
Reference: Federal Register 64(94): 26657-26670 (1999).