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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” use in education, construction, art, and jewelry). FDA does regulate 3D printing equipment and activities when intended to produce regulated medical devices (i.e.,

Medical 98
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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” use in education, construction, art, and jewelry). FDA does regulate 3D printing equipment and activities when intended to produce regulated medical devices (i.e.,

Medical 75
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The Future Of Vision And Eye Care

The Medical Futurist

Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. The Stanford Artificial Retina Project shows great promises. and a specificity of 95.5%. The use of Orca Health’s EyeDecide could bring exactly this result.

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Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

The developing attitudes about food scarcity and deficit models, and mass media’s manufacturing consent, has to be challenged, especially because there is a deep and rich history of Black people as farmers, gardeners, and ranchers that belies what Chimamanda Ngozi Adichie calls the danger of a single story. Da’Shaun L. North Atlantic Books.

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Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

2018 Systematic Review of Systematic Reviews on ACP. Susan: I will share in Indiana, we actually had that as our legal model, that there was a decision making by committee up until 2018. Alex: What did it changed to after 2018? First of all, this does feel primarily like a manufactured controversy. We can work it out!

Illness 73
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Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law Blog

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. 18-1156, 2018 U.S. Specifically, in United States v.