Remove Healthcare Remove Information Remove Manufacturing Remove Relationship
article thumbnail

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

FDA Law

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. After reviewing the information. What is going on here? Draft Guidance. Public Comments.

article thumbnail

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

FDA Law

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. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law

Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. It would also be beyond the scope of what RAS device manufacturers are intending to offer, which is a better surgical tool, not a therapeutic for cancer. 21 U.S.C. §

article thumbnail

Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. That can be incredibly informative.

IT 120
article thumbnail

Ep. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D., of Roetzel & Andress

Physician's Practice

a health care attorney and practice group manager with Roetzel & Andress, joins the show to break down the hidden legal risks of prescribing GLP-1 medications that physicians need to know about, from ensuring informed consent to navigating long-term safety data. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

article thumbnail

Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

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?

IT 102
article thumbnail

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? So when they do meet it, how are you going to be in relationship to it? Eric 24:59 Have to release any embargoed information with us. So I can say anything I want.

Illness 107