FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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Patients Clinic Medical Patient-Centered 52

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. We also talk about the importance of a proactive approach to involving speech-language pathologists in the care of individuals early on with neurodegenerative diseases like dementia and ALS.

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IT Hospital Patient-Centered Individual 125

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. ABIM does not contact individual programs with a lower pass rate to initiate changes to the program.

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Board-Certified Board-Certified Physicians Community Government 40

FDA Law Blog

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. While desirable for patients, validation on multiple platforms can lead to challenges.

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Clinic Patient-Centered Medical IT 59

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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Lab Testing Individual Referral Patient-Centered 52

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic Community 52

FDA Law Blog

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

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Patient-Centered Clinic Patients Provider 49

FDA Law Blog

OCTOBER 11, 2022

Valentine — As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year. Sasinowski & James E.

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Clinic Provider IT Patient-Centered 61

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(e)(2).

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Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

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Supply Chain Individual Provider Patient-Centered 52

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Patient-Centered Manufacturing Clinic Provider 52

PEMBlog

OCTOBER 2, 2024

I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment.

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Diagnosis Management Patient-Centered IT 52

FDA Law Blog

MARCH 17, 2022

Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We We blogged on the final 2016 guideline here on March 17, 2016). Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed.

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GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. Katie, welcome back to GeriPal. What is it called?

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Illness Patient-Centered Screening Clinic 137

Rao Doctor

APRIL 3, 2025

Infrared thermometers, which measure temperature from the forehead or ear, are also prevalent in clinical settings. Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. A comprehensive history includes: A body temperature exceeding 100.4°F

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Diagnosis Management Illness Diagnose 130

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. ABIM’s website features expansive sections on research related to assessment and clinical outcomes.

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Board-Certified Government Community Education 52

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

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Clinic Supply Chain Clinical Practice Patient-Centered 64

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .

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Patient-Centered Illness Healthcare IT 116

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*.

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Board-Certified Board-Certified Physicians Government Community 40

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This is both a research and a clinical interest of yours. Right, Katie?

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Illness Patient-Centered IT Patients 103

GeriPal

FEBRUARY 29, 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.

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IT Patient-Centered Illness Education 127

FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R., MMWR Recomm Rep 2022;71(No. RR-3):1–95.

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Patients Patient-Centered ER Individual 52

The Clinical Problem Solvers

MAY 30, 2022

This discussion is hosted by Naomi Fields, MD, Chioma Onuoha, and Victor Lopez-Carmen MPH, as they interview Dr. Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center.

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Community Patient-Centered Family Families 52

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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IT Patient-Centered Healthcare Illness 106

GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

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Illness IT Patient-Centered Patients 102

GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Amber: Thank you guys.

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Patient-Centered Patients IT Healthcare 112

GeriPal

MARCH 30, 2023

Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma. But my piece in the New England Journal is about being a patient right before awake brain surgery.

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IT Patient-Centered Patients Healthcare 96

GeriPal

DECEMBER 19, 2024

A NY Times article titled Should Patients Be Allowed to Die From Anorexia ? So we’re going to be talking about palliative care for individuals with mental illness. That’s how do we treat the mental health needs of patients with serious medical illness? Oh, yeah, yeah. Good artist. Really tasteful.

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Illness Mental Health IT Patient-Centered 102

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty.

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Patient-Centered Patients IT Hospital 96

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary.

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Illness IT Medical Provider 144

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. This is Eric Widera. Jennifer 04:25 I can take that on.

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Patient-Centered IT Patients Hospital 120

FDA Law Blog

APRIL 20, 2025

This rings particularly true amongst the rare disease patient community, along with many small biotech companies (and their investors) that take on the risk of developing orphan drugs for exceedingly small patient populations. Patients and their families and caregivers have long fought to have a seat at the table with decision-makers.

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Patients Patient-Centered Community Individual 89

GeriPal

DECEMBER 12, 2024

Surrogates often either dont know what patients would want, or think they know but are wrong, or make choices that align with their own preferences rather than the patients. Summary Transcript CME Summary Surrogate decision making has some issues. After making decisions, many surrogates experience regret, PTSD, and depressive symptoms.

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Patient-Centered IT Patients Healthcare 110

FDA Law Blog

NOVEMBER 18, 2024

He states, correctly, that PDUFA user fees make up about 75% of the budget for the Center for Drug Evaluation and Research (CDER). Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023.

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Appointment Vaccination Patient-Centered IT 116

FDA Law Blog

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs. Drug Price Negotiation to Benefit Medicare and Commercial Plans. Controlling Drug Price Increases.

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Manufacturing Supply Chain Patient-Centered Utilities 98