FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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The Clinical Problem Solvers

JANUARY 18, 2021

Published June 10, 2014. Harvard Medical School Primary Care Blog. Creating a segregated medical profession: African American physicians and organized medicine, 1846-1910. Racism denial is deeply ingrained in our society and it needs to be called out and recognized as a system in order to be addressed. 03:55 Jones, C.

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Adventures of a Sick Doctor

JULY 4, 2024

This had been preceded by a fantastic 24 hours in Madrid with another raft of fabulous females, which had come just after the Medical Women's Federation conference in Cambridge where I met loads of lovely people. I opened my diary (an actual physical book, not Outlook) and the silver ribbon is firmly stuck in the week of Wednesday 22nd May.

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The Clinical Problem Solvers

JUNE 12, 2022

His past medical history is significant for hypertension and diabetes mellitus. A problem representation (PR, or Summary Statement) is an evolving, concise summary that highlights the defining features of a case , helping clinicians generate a focused differential diagnosis and identify the next steps in diagnosis and treatment.

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PEMBlog

OCTOBER 31, 2024

However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. 2018 Nov 22;379(21):2002-2014. Parents often use probiotics, like Lactobacillus rhamnosus GG , hoping to reduce the severity of their child’s gastroenteritis. N Engl J Med.

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Adventures of a Sick Doctor

NOVEMBER 7, 2020

The reason for my restricted movements was my Portacath, the small firm hockey-puck device which was implanted in the right side of my chest wall in December 2014. and I say “very little” (knowing from years of medical school that nothing is ever 0%). For six years I haven’t been able to sleep on my right side.

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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AMMD

FEBRUARY 14, 2025

My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. For this reason, medical experts classify DCIS as noninvasive. Medical experts also call these calcifications. In fact, I had a similar situation happen to me not too long ago. What Causes DCIS?

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

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BMJ

JULY 17, 2020

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. 2014 (28 August). National involvement is also needed to facilitate these efforts. doi:10.3389/fcomm.2020.00039

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FDA Law Blog

JUNE 29, 2022

In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”

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FDA Law Blog

SEPTEMBER 13, 2022

Lenz, Principal Medical Device Regulation Expert — It’s been almost 11 years since FDA first clarified use of multiple predicate devices and introduced the concept of Reference Devices in the draft guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], which we blogged about here.

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FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d Polin , 194 F.3d

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FDA Law Blog

OCTOBER 14, 2024

2014); U.S. HTC/Ps in this last category are regulated as drugs or medical devices under the FDCA, or biological products under section 351 of the PHSA, which typically require premarket approval and compliance with the full panoply of FDA regulation. Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. Stem Cell Clinic, LLC , 998 F.3d

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FDA Law Blog

DECEMBER 11, 2023

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 ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA Law Blog

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. It harkens to the paternalism in medicine of the past.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. FDA-2022-E-3124 ).

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FDA Law Blog

JUNE 14, 2022

Though Esai’s Fycompa was initially approved in October 2012, it wasn’t scheduled until January 2014, meaning that Esai lost a little more than a year of patent life awaiting scheduling—in addition to the time spent in regulatory development and review.

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FDA Law Blog

FEBRUARY 27, 2024

In September 2014—nearly ten years ago!—PTE leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § But there are still a couple of possibilities lurking out there! The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s RE 44,599 and U.S.

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Patients IT Provider Individual 59

Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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The Medical Futurist

JUNE 21, 2025

Matthew Enevoldson, PR Manager at SkinVision told The Medical Futurist that technology such as their own is becoming more integrated within the health system, to both ensure that those who need treatment are made aware of it and that those who have an unfounded concern do not take up valuable time and resources.

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GeriPal

OCTOBER 24, 2024

Eric 01:01 So we’re going to be talking about medical cannabis, kind of revisiting it, because we actually had one in 2021 with Ben Han and Bre e Johnston talking about cannabis, including increasing use in older adults and less perceived risk amongst older adults using medical cannabis. Eloise 00:59 Thank you so much.

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Medical IT Patient-Centered Healthcare 98

The Health Policy Exchange

JANUARY 3, 2013

Remarkably, Medicare was fully implemented only 11 months after the bill's signing, overcoming obstacles such as hospital segregation in the South, resistance from physician organizations such as the American Medical Association, and the logistical issues involved in issuing insurance cards to 18 million eligible seniors.

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Doctor On Demand

APRIL 28, 2025

Here’s a closer look at the red-flag symptoms that signal it’s time to visit urgent care for a sore throat: Severe sore throat or trouble swallowing A severe sore throat or trouble swallowing suggests you might have a more complex underlying cause needing urgent medical attention. These symptoms require immediate medical attention.

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The Clinical Problem Solvers

MARCH 4, 2024

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Explain the significance of abolition medicine, and the role of the medical system in upholding and perpetuating carceral logics.

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Community Education Patient-Centered Relationship 52

GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications.

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison Time Stamps 00:00 Opening 00:45 Introductions 03:07 Guest Introduction 1 04:46 Guest Introduction 2 08:15 On the Intersection of Black, Fat, and Trans Communities and the Medical-Industrial Complex 13:35 History and the Racial Underpinnings of Food Shaming in the U.S. During this episode, we hear from Da’Shaun L.

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Community Manufacturing Patients Medical 52

FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. Valentine — Yesterday’s FDA approval of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab-avwa), is historic and is of a magnitude that it may be harbinger for future Agency actions, especially in neuropsychiatric conditions. What do we mean?

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Clinic IT Private Practice Utilities 98

GeriPal

JULY 21, 2022

Because I don’t think we think about that so much in palliative care, but we do in geriatrics. But I believe before we start, somebody has a song request for Alex. Is it you, Emmy? Emmy: It is. Eric: What’s the song? Emmy: I just forgot the name of the song… [laughter]. Alex: Pink Cadillac by Bruce Springsteen? I like that song.

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The Direct Doctors Difference

OCTOBER 21, 2021

As an update to that blog , we want to begin by highlighting again that according to Merritt Hawkins, the average wait time for a new patient appointment with a primary care doctor is 29 days, up 50% from 2014. Many docs are moving out of medicine and fewer medical students and residents want to pursue primary care.

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GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. Today we discuss: What is the best terminology?

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GeriPal

JUNE 29, 2023

On last week’s podcast we interviewed the medical director and the chaplain of the prison’s hospice unit (Hospice in Prison Part 1 ). Alex: Coming up we talk with three pastoral care workers who are inmates who have been volunteering in the hospice at the California Medical Facility prison for some time. So take a listen.

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GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

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Patient-Centered IT Hospital Patients 77

GeriPal

FEBRUARY 2, 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

AUGUST 25, 2022

Eric: Whenever I hear about for-profit, non-for-profit, the differences between them, mostly everybody turns to, I think, your 2014 paper looking at the differences between for-profit and non-for-profit. We’re going to be talking about each one of these papers. But before we do, I think somebody has a song request. Is it you, Melissa?

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