Positron Emission Tomography Drug Products; Safety and Effectiveness of Certain PET Drugs for Specific Indications

概要

The Food and Drug Administration (FDA) is announcing that the Commissioner of Food and Drugs (the Commissioner) has concluded that certain commonly used positron emission tomography (PET) drugs, when produced under conditions specified in approved applications, can be found to be safe and effective for certain indications specified in this document. FDA announces the approval procedures for these PET drugs and indications and invites manufacturers of these drugs to submit applications for approval under this document. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, FDA is issuing a draft guidance for industry entitled "PET Drug Applications--Content and Format for NDA's and ANDA's," which is intended to assist manufacturers that submit applications for approval as specified in this document.