Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation.
The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate.
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D019275:Radiopharmaceuticals / Q000592:standards*; D014055:Tomography, Emission-Computed / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration