Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "PET Drug Applications --Content and Format for NDA's and ANDA's." The draft guidance is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDA's) or abbreviated new drug applications (ANDA's) in accordance with a notice entitled "Positron Emission Tomography Drug Products; Safety and Effectiveness of Certain PET Drugs for Specific Indications" published elsewhere in this issue of the Federal Register.