Draft Guidances for Industry on Medical Imaging Drug and Biological Products; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of three draft guidances for industry on "Developing Medical Imaging Drug and Biological Products." These draft guidances are intended to assist developers of medical imaging drug and biological products (medical imaging agents) in planning and coordinating their clinical investigations and preparing and submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and supplements to NDAs or BLAs. The draft guidances provide information on how FDA will interpret and apply certain provisions in the agency's regulations on in vivo radiopharmaceuticals used for diagnosis and monitoring of diseases and conditions.