Business · 23/04/1997

FDA Releases Draft Guidance for Industry on Content and Format of Abbreviated New Drug Application for Positron Emission Tomography Drug Products

The Food and Drug Administration (FDA) has made available a draft guidance document that outlines the content and format requirements for an Abbreviated New Drug Application (ANDA) for Fludeoxyglucose F18 Injection, a Positron Emission Tomography (PET) drug product, in an effort to assist applicants in submitting their applications and to gather feedback from the public.