Which organization is responsible for regulating radiopharmaceuticals in the context of PET?

The organization responsible for regulating radiopharmaceuticals, particularly in the context of Positron Emission Tomography (PET) and other medical uses of radioactive materials, is the FDA (Food and Drug Administration). The FDA is charged with ensuring the safety, efficacy, and quality of drugs, including radiopharmaceuticals. They oversee the approval process for these substances, providing guidelines that manufacturers must follow to ensure that the products are safe for patient use.

While the NRC (Nuclear Regulatory Commission) does play a key role in the oversight of the use of radioactive materials in various applications, including medical and industrial uses, their primary focus is on radiation safety and the regulation of nuclear reactors and materials. The regulation of specific drugs and biological products, including radiopharmaceuticals, falls under the jurisdiction of the FDA.

Additionally, while organizations like the CDC and EPA might be involved in public health and environmental regulations, respectively, they do not regulate medical products directly. The FDA’s dedicated focus on ensuring that medical substances, including radiopharmaceuticals used in PET, meet stringent safety and efficacy standards makes it the correct answer in this context.