Radiopharmaceutical Indications Need Not Be Disease-Specific - Final Rule
This article was originally published in The Gray Sheet
FDA's final rule on "Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring," allows sponsors to propose indications that refer to a "biochemical, physiological, anatomical, or pathological process or to more than one disease or condition" in cases where the radiopharmaceutical "is not intended to provide disease-specific information."
You may also be interested in...
Recommendations on assessing imaging agent safety, designing clinical development programs and tailoring them to reflect the use of the agents are outlined in guidance titled "Developing Medical Imaging Drug and Biological Products," which addresses contrast agents and diagnostic radiopharmaceuticals in various imaging modalities, including CT, MRI, SPECT and PET. The guidance originally was released in 1998 as a single draft document to address in vivo radiopharmaceuticals for diagnostic and monitoring use (1"The Gray Sheet" May 24, 1999, p. 9). In 2003, the draft was divided into three sections to make it more user-friendly...
Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.