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 IT 52

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. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

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Lab Testing Referral Individual 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

MAY 11, 2023

Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). for the lidocaine group and 4.8 (0.5)

Patient-Centered 52

Patient-Centered Provider IT Patients 52

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. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

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IT Medical Patient-Centered Provider 69

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. Goldilocks zone).

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Diabetes Management Patient-Centered Families 74

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. This discussion is hosted by Ashley Cooper, Sudarshan Krishnamurthy, and new team member Gillette Pierce.

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Community Patient-Centered Mental Health Board-Certified 52

GeriPal

SEPTEMBER 7, 2023

Does it improve outcomes that patients, caregivers, and clinicians care about? hint: 80% can be done in advance by patients or caregivers) Why is it that some oncologists are resistant to conducting a geriatric assessment, yet have no problem ordering tests that cost thousands of dollars? Welcome back, William. William: Thanks so much.

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Patient-Centered IT Patients Clinic 130

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. They just kept at it.

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Medical IT Patient-Centered Healthcare 100

BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. 2 Opioids contribute a large share of this overdose crisis.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. Going into patient’s homes was eye opening. And yet, after assisting the older adult to their feet, the EMS providers would leave.

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Community Transportation IT PCP 116

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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Patient-Centered IT Healthcare Medical 96

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.

Community 52

Community Patient-Centered Families Family 52

GeriPal

FEBRUARY 6, 2025

He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. So let’s just say you have a healthy 55 year old or 65 year old in your clinic. That screening influences kind of further treatment, actually, probably more importantly, patient outcomes.

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Primary Care Diagnosis Screening IT 97

GeriPal

AUGUST 17, 2023

Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”.

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Patient-Centered IT Clinic Patients 98

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. Alex: We are delighted to welcome to the GeriPal podcast, Susan Hickman, who is professor at the Indiana University schools of nursing and medicine, and is director of the IU Center for Aging Research at the Regenstrief Institute. Alex: What did it changed to after 2018?

Illness 73

Illness IT Healthcare Patient-Centered 73

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. If its potentially unsafe, but has robust evidence, well thats most of the treatments we offer seriously ill patients! Think chemotherapy to imminently dying patients, or CPR.

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Patient-Centered IT Patients Illness 79

PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Harding, M., Pediatrics.

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Patient-Centered Patients IT Hospital 52

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. I want to say like 2017, 2018, something like that.

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

OCTOBER 3, 2024

How the act of drawing can help us sloooow down, pay attention to the people and world around us, and ultimately let go… The possibility of incorporating drawings in research and even clinical care. About 25, maybe even 30 years ago, at the Zen center in Green Gulch in Marin. Frank, welcome to the GeriPal podcast.

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IT Patient-Centered Patients Relationship 123

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. On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Randy died February 26, 2023. Welcome, Bob.

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Patient-Centered IT Patients Hospital 84

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). Is that right?

Primary Care 80

Primary Care IT Clinic Illness 80

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. As Redwing’s poem says, “why not live as long as possible?” . AlexSmithMD .

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

FEBRUARY 24, 2022

Should we focus on something else, both from a clinical and a research perspective? We see our patients and our families throughout the illness trajectory into the hospital. And maybe we should have more patient-centered conversations. Like, should we be doing advance care planning? What’s the evidence behind it?

Illness 98

Illness Patient-Centered IT Patients 98

Pamela Wible MD

JUNE 19, 2025

Drawing from her experience running a physician suicide helpline , she speaks candidly about the emotional toll of assembly-line medicine , the link between overwork and doctor suicide , and the revolutionary joy of reclaiming your career by launching your own ideal clinic. Pamela Wible soon discovered why. Let’s hear it for you guys.

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Clinic Nurse Practitioner IT Medical 246

Physician's Weekly

JUNE 25, 2025

Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials. “The pledge is not a mandate,” Mehmet Oz, administrator of the Centers for Medicare & Medicaid Services, said during a news conference.

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Insurance Patient-Centered Patients Government 52

Physician's Weekly

JUNE 17, 2025

Until recently, the only treatment was growth hormone therapy to help patients stay leaner and grow taller, but it didn’t address appetite. This breakthrough for these patients comes as other drugs are revolutionizing how doctors treat obesity, which affects more than 40% of American adults. Kennedy Jr.

Patient-Centered 52

Patient-Centered Emergency Room Insurance Patients 52

PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. You should develop a specific plan for each patient with each patient. Pediatrics. doi: 10.1542/peds.2018-1009. PMID: 30297499.

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Illness Vaccination Families Family 59

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs. Controlling Drug Price Increases.

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Manufacturing Supply Chain Patient-Centered Utilities 98