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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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

Medical 75
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The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law Blog

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? We should be able to trust all the data that comes from our governing board.

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there. What do we do to very concretely provide heat shelters and cool shelters? Leslie: Well, yes, thank you, Ruth.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.