FDA Law Blog

JANUARY 13, 2025

Failure to list coconut as an allergen has also been mentioned in several warning letters (see, e.g., here ) and as the reason for several product recalls, including a recent Class I recall in April 2024 (see also, e.g., Class II recalls in 2018 and 2022 for listing coconut as an ingredient but failing to disclose coconut in the allergen statement).

Patient-Centered 105

Patient-Centered IT Patients 105

The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. Advocate for transition planning resources as patients age out of pediatric care. 2018 May/Jun;79(3):17r11506.

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Family Families Patient-Centered Physicals 77

FDA Law Blog

DECEMBER 13, 2023

Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

Patient-Centered 59

Patient-Centered Medical Patients IT 59

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

FDA Law Blog

JULY 7, 2021

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. FDA cleared 510(k)s for GEDs in the 1990s.

Medical 52

Medical Patient-Centered Patients IT 52

PEMBlog

APRIL 20, 2023

Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors.

Individual 52

Individual Patient-Centered Patients IT 52

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 Family 74

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.

Patients 52

Patients Patient-Centered Clinic Community 52

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] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

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IT Medical Patient-Centered Provider 69

The Clinical Problem Solvers

AUGUST 25, 2020

Her definition centers the idea that Black individuals did not inherit the diseases they disparately suffer from, but they inherited a disadvantaged system that creates the stark health disparities we see today. This starts with self-education and a commitment to speak up when blatant examples of racism come up in the work space and beyond.

Community 52

Community Patient-Centered Relationship Education 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. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 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). Is there evidence for the J-Tip?

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. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 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? But does the geriatric assessment do anything?

Patient-Centered 130

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? 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?

Medical 100

Medical IT Patient-Centered Healthcare 100

GeriPal

OCTOBER 10, 2024

Alex 01:23 And we’re delighted to welcome DorAnne Donesky, who is a palliative care nurse practitioner at Queen of the Valley Medical center in Napa and professor emeritus at the UCSF School of Nursing. Show me your scars.” Scars, really? I’ve been there. You probably have too. Michelle 01:22 Thanks for having us today.

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Screening IT Family Families 121

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.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. They were stunned by the number of calls for lift assistance for older adults who had fallen. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. Alex: That is true.

Community 116

Community Transportation IT PCP 116

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.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

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.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

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. and a professor.”

Community 52

Community Patient-Centered Family Families 52

GeriPal

FEBRUARY 6, 2025

He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. To start things off, Nate’s a returning guest. Nate, welcome back to the GeriPal Podcast. Nate 00:25 Thanks for having me. Great to be back. And my wife went to over, I want to say, 20 concerts. I loved it.

Primary Care 97

Primary Care Diagnosis Screening IT 97

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. 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.

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Illness IT Healthcare Patient-Centered 73

GeriPal

AUGUST 17, 2023

However, as noted in our editorial published with the donanemab trial , the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer. However, they are none of these. Welcome back to the GeriPal podcast, Jason.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

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.

Patient-Centered 79

Patient-Centered IT Patients Illness 79

PEMBlog

JUNE 5, 2024

Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Cervical Spine Injuries are fortunately rare in children.

Patient-Centered 52

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 Hospital 96

FDA Law Blog

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). A registered nurse also admitted she replaced fentanyl and hydromorphone with saline solution for administration to patients. The tech’s husband distributed the drugs in the community.

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Hospital Patient-Centered Medical Provider 59

GeriPal

OCTOBER 3, 2024

Alex 00:08 UCSF’s Division of Palliative Medicine are looking to build on their research and clinical programs and are interviewing candidates for the associate chief of research position and for full time physician faculty to join them in the in-patient and out-patient settings. Sit down and draw each other for only one minute.

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IT Patient-Centered Patients Relationship 123

GeriPal

MAY 12, 2022

Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Prognosis communication and the subtle ways we may communicate it without intention. Social pain and loneliness. Community-based palliative care networks . Raj’s reflections on the state of palliative care in the US. Transcript.

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Community IT Relationship Healthcare 116

Tiny Physician

MARCH 30, 2022

Archana Sharma committed suicide because of the harassment by the bystanders of the patient who died at her hospital. However, she found herself in trouble when one of her patients, whom she treated at her hospital, died due to postpartum hemorrhage (bleeding from the birth canal after delivery). link] What is postpartum hemorrhage?

Hospital 52

Hospital Government Patient-Centered Medical 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. On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Is 4% meaningful? Welcome, Bob. Bob: Thank you.

Patient-Centered 84

Patient-Centered IT Hospital Patients 84

GeriPal

MARCH 27, 2025

Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). Was there really a causal connection between the intervention, new advance directives, and higher rates of potentially burdensome interventions? Jasmine, is it you?

Primary Care 80

Primary Care IT Clinic Illness 80

GeriPal

APRIL 21, 2022

Poetry holds us in that liminal space so many of our patients are in. Alex: We also have Mike Rabow, who is director of palliative care at the Cancer Center at UCSF. The impossiblity which is life, which is everything, and death, which is the end of life. To let it go. . Welcome to the GeriPal podcast, Redwing. Redwing: Thank you.

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

FEBRUARY 24, 2022

Since then there has been a lot of back and forth, with even a couple of podcasts from us, several JAMA viewpoints, and most recently a series of published replies from leaders in the field on why ACP is still valuable (see below for references). . Despite all of these publications, I’m still left at a loss of what to think about it all.

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Illness Patient-Centered IT Patients 98