Healthcare Manufacturing Patients Relationship 
FDA Law Blog
MAY 7, 2025
The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th
FDA Law Blog
OCTOBER 14, 2021
Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. These clearances are based on short-term (30 day) patient follow up.
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FDA Law Blog
DECEMBER 12, 2022
Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.
FDA Law Blog
JULY 5, 2023
Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(d) Draft Guidance III.B.2(f) 2(f) at 9-10.
GeriPal
JUNE 20, 2024
Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. There, we may do very poorly, where we can describe our beautiful models of all the kind of risk factors and contributors, ranging from organ level, patient level, behavioral, contextual, environmental.
Physician's Practice
JUNE 9, 2025
68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L.
GeriPal
MAY 5, 2022
COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And nurses and other healthcare practitioners knew nothing about it. Over-the-counter hearing aids: What will it mean for older Americans?
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