FDA Law Blog

NOVEMBER 6, 2024

As the Court explains, an orphan drug may not be the “same drug” as the same active moiety under the Orphan Drug Act and FDA’s longstanding implementing regulations if one is “clinically superior” than the other by way of greater efficacy, greater safety, or major contribution to patient care (“MC-to-PC”). Black Ball Freight Serv. ,

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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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FDA Law Blog

APRIL 6, 2025

Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases.

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FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. What, if any, unintended consequences may result from the proposed phaseout policy to certain patient populations (for example, Medicare beneficiaries, rural populations, etc.) Change to the IVD definition First, the mechanics of the change.

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Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. Neil Baum, MD Successful practices do not follow others; rather, they make their own paths and follow their own pathways and agendas.

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FDA Law Blog

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. In this case, the Supreme Court provided greater clarity on how to interpret that requirement.

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FDA Law Blog

JUNE 22, 2022

It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed. DEA regulations require “adequate security” but do not specially require cameras in health care facilities.

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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. The following is a summary of the spring meeting.

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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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GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . We got some really special guests with us. 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. Transcript. This is Eric Widera.

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New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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FDA Law Blog

JUNE 10, 2024

The hospital also “entered into a Memorandum of Agreement with the DEA requiring Palomar Health to undertake additional measures to increase security, implement specialized training, and to handle controlled substances properly and safely.” DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ).

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PEMBlog

JULY 10, 2024

Labudde, Jane Lee; A Review of Syphilis Infection in Pediatric Patients. link] Centers for Disease Control and Prevention. ” Centers for Disease Control and Prevention, 2021. Centers for Disease Control and Prevention. ” Centers for Disease Control and Prevention, 2021. . Pediatr Rev.

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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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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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GeriPal

MARCH 20, 2025

Recently, discussion has emerged about how these issues intertwine in caring for patients with advancing dementia who have stated that they would not want to continue living in that condition: for those with an advanced directive to stop eating and drinking, how do we balance caring for their rational past self and their experiential current self?

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GeriPal

APRIL 26, 2024

Who spends the most time with the patient in the infusion center? And we’re delighted to welcome Jenny back to the GeriPal podcast, Jenny Blumenthal-Barby, who’s a philosopher and bioethicist and associate director for the Center for Medical Ethics and Health policy at the Baylor College of Medicine. Doing home care?

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GeriPal

FEBRUARY 2, 2023

That happened to me when reading “Range: Why Generalists Triumph in a Specialized World.” Alex: This was the National Palliative Care Research Center’s Annual Foley retreat for investigators, researchers. Summary Transcript Summary Sometimes you read a book and get a flash of insight – that “ah ha!” Eric: Yeah.

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Pamela Wible MD

JUNE 19, 2025

In order to heal her patients she first had to heal her ailing profession. And this is a medical system that needs to be disrupted because our medical system (as you know) is endangering the lives of patients right now—and physicians. I give you Dr. Pamela Wible. Born into a family of physicians who warned her not to pursue medicine.

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PEMBlog

MAY 9, 2024

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. All five of those patients with meningitis had a concerning exam, and four out of five were less than 12 months of age.

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