Remove Events Remove Healthcare Remove Hospital Remove Physicals
article thumbnail

Risk of thrombotic events should not exclude transgender people from receiving hormone therapy, says new guidance

Medical Xpress

The negative mental and physical effects of withholding gender-affirming hormone therapy (GAHT) from transgender people may outweigh the risk of GAHT-associated venous thromboembolism (VTE), underscoring the need for a thorough upfront discussion by healthcare provider and patient, according to a study led by investigators from Massachusetts General (..)

article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. The PR goes on to state that the FD&C Act definition of a device does not turn on where or by whom a test system is “manufactured.”

Insiders

Sign Up for our Newsletter

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

article thumbnail

The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law

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. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d) Draft Guidance III.B.2(f) 2(f) at 9-10.

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. My own work focuses on hospitalization and health utilization over time.

IT 102
article thumbnail

Transforming the Culture of Dementia Care: Podcast with Anne Basting, Ab Desai, Susan McFadden, and Judy Long

GeriPal

I think … There’s so few, seriously, from the hospital system and the pathologizing systems to the more social care intervention work that Susan and I really do. We need to learn from them that they have moved on, so how do we not dwell in the past negative events? How do we move on? She had been included.

Community 101
article thumbnail

Deprescribing Super Special III: Constance Fung, Emily McDonald, Amy Linsky, and Michelle Odden

GeriPal

And our next guest is Amy Linsky, who’s a physician and researcher at the VA Boston Healthcare System and associate professor at Boston University University. I’m an internist, so when I hospitalize patients, 1 in 8 of my patients now takes pregabalin or gabapentin. Emily, welcome to the GeriPal Podcast. Alex 00:24 Great.

article thumbnail

Updates in ID and Nephrology: Lona Mody, Rasheeda Hall, Devika Nair, Sonali Advani

GeriPal

It’s Lona Mody who is a translational infectious disease researcher at the University of Michigan and VA Ann Arbor Healthcare System. Alex: And we are also delighted to welcome Devika Nair, who is a nephrologist at Vanderbilt University Medical Center in Tennessee Valley VA Healthcare System. Our first guest is a repeat guest.