article thumbnail

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

Firm-generated communications must meet the general recommendations in the Draft Guidance and “should be truthful, non-misleading, factual and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the presented information.”

Clinic 64
article thumbnail

Podcast: AI, innovation, and value-based care in medicine

Permanente Medicine

These priorities include supporting the physician workforce, utilizing data and predictive interventions to improve patient outcomes, and boosting quality and affordability for patients. I know for a fact that the government or legislators looked to us in Permanente. And then putting that on steroids with AI.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Corporate Liability from Employee Diversion: Costly on Many Fronts

FDA Law Blog

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. DEA regulations require “adequate security” but do not specially require cameras in health care facilities. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36

article thumbnail

Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

So I think we’re poised now with the guide model and with the evidence we have about healthcare utilization, impact on caregivers, course of dementia, comorbidity management and all of that. I don’t have access to change the levers of government. Eric 19:56 Okay, but I’m a primary care provider. But I don’t.

Screening 120
article thumbnail

Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” GSK skinny label case , the U.S.

article thumbnail

Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. Patient that are agitated should always be treated with dignity and respect.

article thumbnail

Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

He created fee for service, special fee for depression. The typical utilization of inappropriate hospitalization and emergency room and total cost of care. Just to let you know, Eric, we have to give the credit to our federal government. And when we made that with David and other, we talk with Jürgen Unützer. Think about CPC+.