Draft guidance for industry on developing medical imaging drugs and biologics; availability--FDA. Availability of guidance.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Developing Medical Imaging Drugs and Biologics." This draft guidance is intended to assist developers of drug and biological products used for medical imaging, as well as radiopharmaceutical drugs used in disease diagnosis, in planning and coordinating the clinical investigations of, and submitting various types of applications for, such products. The draft guidance also provides information on how the agency will interpret and apply provisions in the proposed regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring, which published in the Federal Register of May 22, 1998 (63 FR 28301).
D001688:Biological Products; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D017408:Guidelines as Topic; D006801:Humans; D019275:Radiopharmaceuticals; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products; D019275:Radiopharmaceuticals