Three Guidances on Medical Imaging Drugs and Biologics
05/19/2003
Federal Register Notice: FDA is making available 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 INDs, NDAs, BLAs, 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. To download the guidances, click here (Part I, II, III). To view this notice, click here.
