FDA issues imaging drug guidance
This article was originally published in The Gray Sheet
Executive Summary
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...
You may also be interested in...
Radiopharmaceutical Indications Need Not Be Disease-Specific - Final Rule
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."
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.