FDA Law

AUGUST 4, 2022

Further, “there is little utility in comparing the language of the BIS to that of the AKS.”. Most of these cases have settled out of court (see, for example, Actelion Pharmaceuticals , 2018; Astellas Pharma and Amgen , 2019; Gilead Sciences , 2020). The Lesson of this Case.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

JULY 7, 2022

The first was to develop labeling beyond the DFL and the second was to propose “additional conditions that a consumer must fulfill” with the examples self-selection tests utilizing a mobile app or a requirement for the consumer to affirm they have watched a video or read text about use of the drug.

Healthcare Professional 52

Healthcare Professional Utilities Provider IT 52

FDA Law

FEBRUARY 28, 2022

This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

Manufacturing 45

Manufacturing Provider Consulting IT 45

GeriPal

FEBRUARY 15, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Community 114

Community Transportation IT PCP 114

FDA Law

JANUARY 4, 2023

Upon finalization of the guidance a year and a half later in June 2018 (which gave those who follow ad/promo guidance documents whiplash given the number of still-in-draft guidances) FDA expanded its enforcement discretion to include communications about unapproved uses of approved products.

Patients 64

Patients Provider IT Utilities 64

The Clinical Problem Solvers

FEBRUARY 8, 2023

Isom continues the conversation around the intentionality of these structural processes and the language that frames the racialization of substance use in the United States by lawmakers, media, and the healthcare profession. 2018 Jun;46(2):404-421. Academic Psychiatry , 45 (1), 54–60. link] James K, Jordan A. J Law Med Ethics.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. I wonder if we can just start off just going back a little bit because we had Randy on back in 2018 talking about Jumpstart, priming patients to do goals of care conversations. Am I summarizing that right?

Patient-Centered 83

Patient-Centered IT Patients Hospital 83

GeriPal

FEBRUARY 24, 2022

And I’m worried about all of us as healthcare workers, but particularly… And when I say particularly those in the hospital, because they are just tired. If they had a healthcare agent, then this would be better, right? They’re looking at difficult outcomes, utilization outcomes, right? What are your values?

Illness 98

Illness Patient-Centered IT Patients 98

FDA Law

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59