Positron Emission Tomography Drug Products; Draft Guidance for Industry on Content and Format of an Abbreviated New Drug Application; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Content and Format of an Abbreviated New Drug Application (ANDA)--Positron Emission Tomography (PET) Drug Products.'' This draft guidance is intended to assist applicants who wish to submit an ANDA for Fludeoxyglucose F18 Injection. The draft guidance is one of several topics to be discussed at an April 28, 1997, FDA workshop on PET radiopharmaceutical drug products. The agency is requesting comments on this draft guidance.