Healthcare, Individual, Manufacturing and Presentation

Researchers Propose Solutions to Improve GLP-1 RA Access

Physician's Weekly

JUNE 18, 2025

Cost-sharing interventions and patient education can help improve access to GLP-1 receptor agonists for patients with obesity, according to an abstract presented at the AACE Annual Meeting 2025. Other Persistent Barriers & Potential Solutions In another article not presented at the meeting, Stephanie W.

Healthcare Professional

Healthcare Professional Insurance Manufacturing Healthcare

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

FDA Law

DECEMBER 12, 2022

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. The approved devices already have patient‑directed labeling that FDA has approved. What is going on here?

Manufacturing

Manufacturing Provider Patients Medical

Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

JUNE 20, 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.

IT

IT Patient-Centered Patients Clinic

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

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

Patients Clinic Medical Patient-Centered

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law

JANUARY 26, 2022

Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate. Creating TV commercials ain’t cheap nor is the air time for them.

IT

IT Education Utilities Patient-Centered

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing

Manufacturing Provider Physicals Electronics

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction.

Medical

Medical Diagnosis Healthcare Clinic

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

MARCH 24, 2022

Susan: I’ll just say, I think that could happen outside of the healthcare setting pretty easily and frequently does. Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences. Rebecca: Agreed.

Illness

Illness IT Healthcare Patient-Centered

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

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. 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 we did have.

Illness

Illness IT Patient-Centered Patients

FDA-Approved Labeling: Is Enough Enough?

FDA Law

AUGUST 21, 2023

Thus, Defendants argued that FDA already required the warning for pregnancy, rendering the decision to use it during pregnancy to a healthcare professional, and that FDA had considered the risks of in utero exposure and rejected the addition of those risks to the labeling.

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

FDA Law

SEPTEMBER 8, 2022

Recognizing the problems that high prescription drug costs pose to patient access to medications, many drug manufacturers have created copay assistance programs to help patients afford the copays and deductibles for their medications. These prohibitions are often referred to as copay accumulator adjustment programs.

Insurance

Insurance Patients Manufacturing Patient-Centered

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law

MAY 26, 2025

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. Such a message may understandably deter the targeted conduct to avoid such a risk. MedImmune, Inc. Genentech, Inc., Gardner , 387 U.S. 136, 152 (1967)).

Manufacturing

Manufacturing Provider Medical General Practice

Primary Care Digest

Researchers Propose Solutions to Improve GLP-1 RA Access

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

Trending Sources

Urinary Incontinence Revisited: George Kuchel & Alison Huang

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

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

FDA-Approved Labeling: Is Enough Enough?

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

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