News | Coronavirus (COVID-19) | June 25, 2020

FDA Launches "FDA Insight" Podcast Featuring FDA Commissioner

he FDA launched the first “FDA Insight” podcast, featuring FDA Commissioner Stephen Hahn, M.D., and FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D., discussing FDA's COVID-19 efforts, including the drug development process for a COVID-19 treatment.

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June 25, 2020 — The FDA launched the first “FDA Insight” podcast, featuring FDA Commissioner Stephen Hahn, M.D., and FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D., discussing FDA's COVID-19 efforts, including the drug development process for a COVID-19 treatment. Future FDA Insight podcasts will feature Hahn, Shah, and other FDA leaders’ insights into issues facing the agency — including the COVID-19 pandemic and other emerging topics.

You can listen to the first podcast, FDA Insight: Fighting COVID-19 at the FDA, here.

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Figure 1. A: COVID-19-related spatial covariance pattern of cerebral glucose metabolism overlaid onto an MRI template. Voxels with negative region weights are color-coded in cool colors, and regions with positive region weights in hot colors. B: Association between the expression of COVID-19-related covariance pattern and the Montreal Cognitive Assessment (MoCA) score adjusted for years of education. Each dot represents individual patient. C: Results of a statistical parametric mapping analysis. Upper row illustrates regions that show significant increases of normalized FDG uptake in COVID-19 patients at 6-months follow-up compared to the subacute stage (paired t test, p < 0.01, false discovery rate-corrected). Bottom row depicts regions that still show significant decreases of normalized FDG uptake in COVID-19 patients at 6-months follow-up compared to the age-matched control cohort at an exploratory statistical threshold (two-sample t test, p < 0.005). Image Credit: G Blazhenets et al., Department of Nuclear Medicine, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg

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Cardiac Magnetic Resonance Imaging in Athletes With Clinical and Subclinical Myocarditis A-D, Athlete A with subclinical possible myocarditis was asymptomatic with normal electrocardiogram (ECG), echocardiogram, and high-sensitivity troponin findings. A, T2 mapping showing elevated T2 in basal-mid inferolateral wall in short axis view. B, late gadolinium enhancement (LGE) in the basal inferolateral wall in short axis view. C, Postcontrast steady state-free precession (SSFP) images showing contrast uptake in the basal-mid inferolateral wall in short axis view. D, LGE in the inferolateral wall in 3-chamber view. E-H, Athlete B with subclinical probable myocarditis was asymptomatic with normal ECG, normal echocardiogram, and elevated high-sensitivity troponin findings. E, T2 mapping showing elevated T2 in the anteroseptal wall in short axis view. F, LGE in the anteroseptal wall in 3-chamber view. G, T2 mapping showing elevated T2 in the anteroseptal wall in 3-chamber view. F, Postcontrast SSFP image showing pericardial effusion in short axis view. I-K, Athlete C with clinical myocarditis and chest pain, dyspnea, abnormal ECG, normal echocardiogram, and normal troponin findings. I, T2 mapping showing elevated T2 in the lateral wall short axis view. J, Postcontrast SSFP images showing contrast uptake in midlateral wall in short axis view. K, LGE in the epicardial midlateral wall in short axis view. L-N, Athlete D with clinical myocarditis, chest pain, abnormal ECG, echocardiogram, and troponin findings. L, T1 mapping showing elevated native T1 in midlateral wall in short axis view. M, T2 mapping showing elevated T2 in the midlateral wall in short axis view. N, LGE in the epicardial midlateral wall in short axis view. IR indicates inferior right view; IRP, inferior, right, posterior view; PLI, posterior, left, inferior view; SL, superior left view; SLA, superior, left, anterior view. Image courtesy of JAMA Cardiol. Published online May 27, 2021. doi:10.1001/jamacardio.2021.2065

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Result of the Hoffman brain phantom study. Top row: same PET slice reconstructed with A) 2mm static OSEM, B) 1mm static OSEM, C) proposed SR method and D) corresponding CT slice (note that the CT image can be treated as a high-resolution reference). Middle row: zoom on region of interest for corresponding images. Bottom row: Line profiles for corresponding data. Image created by Y Chemli, et al., Gordon Center for Medical Imaging: Department of Radiology Massachusetts General Hospital, Harvard Medical School, Boston, MA.

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