Evaluation of radiation doses from radioactive drugs

Radioactive new drugs are regulated by the Food and Drug Administration (FDA) in the United States. Before a new drug can be marketed it must have an approved New Drug Application (NDA). Clinical investigations of a radioactive new drug are carried out under a Notice of Claimed Investigational Exemption for a New Drug (IND), submitted to the FDA. In the review of the IND, radiation doses are projected on the basis of experimental data from animal models and from calculations based upon radiation characteristics, predicted biodistribution of the drug in humans, and activity to be administered. FDA physicians review anticipated doses and prevent clinical investigations in humans when the potential risk of the use of a radioactive substance outweighs the prospect of achieving beneficial results from the administration of the drug. In the evaluation of an NDA, FDA staff attempt to assure that the intended diagnostic or therapeutic effect is achievable with the lowest practicable radiation dose. Radiation doses from radioactive new drugs are evaluated by physicians within the FDA. Important radioactive new drugs are also evaluated by the Radiopharmaceuticals Advisory Committee. FDA also supports the Center for Internal Radiation Dosimetry at Oak Ridge, to provide information regarding in vivo distribution and dosimetry to critical organs and the whole body from radioactive new drugs. The process for evaluation of radiation doses from radioactive new drugs for protection against use of unnecessary radiation exposure by patients in nuclear medicine procedures, a