SNMMI Leadership Update: FDA approval of imaging agents: an exciting investment in nuclear medicine

SW Schwarz - 2017 - Soc Nuclear Med
Axumin (fluciclovine 18F injection), for detecting biochemical recurrence of prostate cancer,
and NETSPOT (68Ga-dotatate injection), for localization of somatostatin receptor–positive …

FDA approves 18F-fluciclovine and 68Ga-DOTATATE products

P Dotatate - J. Nucl. Med, 2016 - Soc Nuclear Med
Through its Priority Review mechanism, the US Food and Drug Administration (FDA)
recently approved 2 radiopharmaceutical products for use as diagnostic PET agents. The …

Proceedings: Pathways for Successful Translation of New Imaging Agents and Modalities—Phase III Studies

SS Gambhir, LK Shankar, E Rosenthal… - Journal of Nuclear …, 2019 - Soc Nuclear Med
Significant advances continue in the development of cancerspecific molecular imaging
agents and modalities for diagnosing, staging, and treating various cancer types. For these …

SNMMI Leadership Update: Putting Patients First: A Year in Review

RL Wahl - 2022 - Soc Nuclear Med
Over the past year, SNMMI has implemented many new initiatives focused on putting the
patient first. As SNMMI president, I have worked with our dedicated leadership, volunteers …

SNMMI Leadership Update: Challenges, Opportunities, and Accomplishments

H Jadvar - Journal of Nuclear Medicine, 2016 - Soc Nuclear Med
My year as president of SNMMI has flown by. It has been a year of challenges, opportunities,
and, I'm pleased to say, accomplishments. The Therapy Center of Excellence (CoE) is up …

The Medical Imaging & Technology Alliance conference on research endpoints appropriate for Medicare coverage of new PET radiopharmaceuticals

BJ Hillman, RA Frank, BC Abraham - Journal of Nuclear Medicine, 2013 - Soc Nuclear Med
The outcomes of a 2011 Medical Imaging & Technology Alliance (MITA) conference helped
shape considerations about what might be the most appropriate pathways for the regulatory …

The future of USP monographs for PET drugs

S Schwarz, J Norenberg, M Berridge… - Journal of Nuclear …, 2013 - Soc Nuclear Med
(FDAMA) required that PET drugs be prepared according to US Pharmacopeia (USP)
compounding standards and PET drug monographs until the Food and Drug Administration …

[PDF][PDF] The Australasian Radiopharmaceutical Trials Network: clinical trials, evidence, and opportunity

RJ Francis, DL Bailey, MS Hofman… - Journal of Nuclear …, 2021 - Soc Nuclear Med
Recent advances in technology and discovery have led to a key role for nuclear medicine in
precision health and individualized patient care. As we enter this era of promise and growth …

[PDF][PDF] How flexible is USP general Chapter< 823>?

JC Hung - 2011 - Soc Nuclear Med
“Radiopharmaceuticals for Positron Emission Tomography—Compounding,” as published in
the current version of the United States Pharmacopeia (USP)(1), provides extensive quality …

The cost of bringing a radiopharmaceutical to the patient's bedside

AD Nunn - Journal of Nuclear Medicine, 2007 - Soc Nuclear Med
The approval of new imaging agents has slowed, much as for therapeutic drugs. Schering
and Amersham, for instance, each spent about $150 million a year for the period 1999–2004 …