The academic NDA: justification, process, and lessons learned
JJ Sunderland - Journal of Nuclear Medicine, 2020 - Soc Nuclear Med
The University of Iowa recently completed a 4-y expedition into the uncharted waters of the
Food and Drug Administration (FDA) new-drug application (NDA) process that ultimately …
Food and Drug Administration (FDA) new-drug application (NDA) process that ultimately …
Aetna and 68Ga-DOTATATE: A Sequel to “The Injustice of Being Judged by the Errors of Others”()
J Czernin, F Ceci - Journal of Nuclear Medicine, 2018 - Soc Nuclear Med
More than a year ago, the US Food and Drug Administration (FDA) and the Centers for
Medicare and Medicaid services (CMS) approved and reimbursed 68Ga-DOTATATE PET …
Medicare and Medicaid services (CMS) approved and reimbursed 68Ga-DOTATATE PET …
Proceedings: Pathways for Successful Translation of New Imaging Agents and Modalities—Phase III Studies
Significant advances continue in the development of cancerspecific molecular imaging
agents and modalities for diagnosing, staging, and treating various cancer types. For these …
agents and modalities for diagnosing, staging, and treating various cancer types. For these …
Perspective on how the FDA should review diagnostic radiopharmaceuticals
SW Schwarz, B Clarke - Journal of Nuclear Medicine, 2018 - Soc Nuclear Med
This article provides readers with some background on concerns raised by Dr. Marcus about
the evaluation of radiopharmaceuticals in this issue of The Journal of Nuclear Medicine (1) …
the evaluation of radiopharmaceuticals in this issue of The Journal of Nuclear Medicine (1) …
PET is alive and well
HN Wagner - Journal of Nuclear Medicine, 2007 - Soc Nuclear Med
In a recent article on DOTmed. com entitled ''Is There Life After PET?''Wayne Webster,
founder of ProActics Consulting, wrote that ''PET is nearing the end of its life cycle and will …
founder of ProActics Consulting, wrote that ''PET is nearing the end of its life cycle and will …
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 …
compounding standards and PET drug monographs until the Food and Drug Administration …
[HTML][HTML] Non-FDG PET/CT in Diagnostic Oncology: a pictorial review
F Giammarile, P Castellucci, R Dierckx… - European journal of …, 2019 - Springer
Positron emission tomography/computed tomography (PET/CT) is currently one of the main
imaging modalities for cancer patients worldwide. Fluorodeoxyglucose (FDG) PET/CT has …
imaging modalities for cancer patients worldwide. Fluorodeoxyglucose (FDG) PET/CT has …
PET Radiopharmaceuticals: What's new, what's reimbursed, and what's next?
BN Clarke - Journal of nuclear medicine technology, 2018 - Soc Nuclear Med
The field of molecular imaging is undergoing a period of expansion. The number of
radiopharmaceutical ligands, therapeutic isotope combinations, and targets continues to …
radiopharmaceutical ligands, therapeutic isotope combinations, and targets continues to …
[CITATION][C] A Strategic Approach to Advancing Nuclear Medicine and Molecular Imaging
HR Nadel - Journal of Nuclear Medicine, 2023 - Soc Nuclear Med
SNMMI has been working hard on multiple fronts to ensure patients have adequate and
equitable access to appropriate nuclear medicine procedures. SNMMI and the American …
equitable access to appropriate nuclear medicine procedures. SNMMI and the American …
Regulatory requirements for PET drug production
SW Schwarz, D Dick, HF VanBrocklin… - Journal of Nuclear …, 2014 - Soc Nuclear Med
The Food and Drug Administration (FDA) issued the final rule for title 21 of Code of Federal
Regulations part 212 regarding the regulations on current good manufacturing practice for …
Regulations part 212 regarding the regulations on current good manufacturing practice for …