In 2007, the Food and Drug Administration requested that manufacturers of all approved
gadolinium-based contrast agents (GBCAs), drugs widely used in magnetic resonance imaging, …

Prostate cancer is expected to remain the most commonly diagnosed cancer in US men in
2021, with the American Cancer Society estimating 248,530 new cases. 1 Although many …

Research and development of medical countermeasures (MCMs) for radiation-induced lung
injury relies on the availability of animal models with well-characterized pathophysiology, …

The safety and efficacy expectations for US Food and Drug Administration (FDA) approval
of diagnostic radiopharmaceuticals (DRs) are described in laws that broadly apply to all …

1561 Background: For radioactive drugs, 21 CFR 312.23(a)(10)(ii) requires that IND submissions
include sufficient data from animal or human studies to allow a reasonable estimation …

… “Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate
cancer,” says Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine …

… Presenters and their topics included: Mills,‘‘Imaging Biomarkers and Imaging Standardization
for Clinical Trials’’; Alex Gorovets, medical officer,‘‘Development of Imaging Products: …

… The authors would like to express gratitude to Alex Gorovets, MD, for the helpful discussion
and expertise regarding medical imaging products. The authors also acknowledge Amy …

On May 23, 2007, the Food and Drug Administration (FDA) requested that a “black box”
warning (one of the more extreme mechanisms that the FDA may invoke for calling attention to …

… Presenters and topics tentatively scheduled include George Mills, MD, MBA, who will speak
on Imaging Biomarkers and Imaging Standardization for Clinical Trials; Alex Gorovets, MD, …