FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. By Larry K. Houck Last month the U.S. 81, 86, 251. 81, 89, 251.

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PEMBlog

MAY 1, 2025

Only about 25% of infected individuals will have this classic rash syndrome. Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. But what is it?

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FDA Law Blog

JUNE 29, 2022

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Prior to issuance of this Draft Guidance, information about this previously little-used process was included in a variety of sources we describe below.

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FDA Law Blog

MARCH 4, 2024

Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products. API and its source and any alternative sources; associated medical devices), and expected duration of the interruption.

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FDA Law Blog

JUNE 23, 2021

In 2012 we at the Agency, under Dr. Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. It harkens to the paternalism in medicine of the past.

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Pamela Wible MD

JUNE 20, 2025

Psychiatrists define burnout as a job-related dysphoria in an individual without major psychopathy—meaning you’re normal; your job is killing you. It’s a growing crisis affecting over half of all doctors in the U.S., and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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FDA Law Blog

FEBRUARY 27, 2024

Consequently, because both applications were approved at the same time, both applications represent the first permitted commercial marketing or use of the product or the individual active ingredients, as outlined under 35 U.S.C. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). l 56(c)(4) and 37 C.F.R.

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Common Sense Family Doctor

MAY 11, 2025

Effective treatments include referral to self-help groups such as Gamblers Anonymous , group or individual cognitive behavioral therapy , motivational interviewing, and naltrexone. People with gambling disorder are at increased risk for self-harm and suicide attempts.

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GeriPal

MARCH 2, 2023

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. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

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Patient-Centered IT Healthcare Medical 96

PEMBlog

JUNE 2, 2025

While elucidating the underlying cause of the hypertensive emergency is important for a patients ongoing care, your role in the pediatric ED is to: 1) stabilize airway, breathing, circulation; 2) minimize worsening end-organ dysfunction by acutely lowering blood pressure; and, 3) start work up to evaluate cause (Patel 2012).

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FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 12, 2012) (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed.

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The Clinical Problem Solvers

NOVEMBER 16, 2020

This is done on an individual level, by offering existing support and resources, as well as on a systemic level through advocacy. [link] This is the first episode of a three-part series on understanding and dismantling race-based medicine by unearthing its origin and exposing the paucity of rigorous evidence in support of it. For genetics?

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Clinical Practice Clinic Medical Education 52

GeriPal

MARCH 7, 2024

There’s an organization that I took my training from, which began, I want to say, in 2012. But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer.

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FDA Law Blog

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. Laryngomalacia, is the most common cause of infant stridor. Early diagnosis is crucial as it can impact a child’s growth and development. Most infants get better on their own, but those with severe symptoms need surgical interventions like supraglottoplasty. Treasure Island (FL): StatPearls Publishing; 2023 Jan-.

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Diagnosis IT Diagnose Patients 52

GeriPal

AUGUST 1, 2024

Summary Transcript Summary What is a healthy diet and how much does it really matter that we try to eat one as we age? That’s the topic of this week’s podcast with three amazing guests: Anna Pleet, Elizabeth Eckstrom, and Emily Johnston. Emily Johnston is a registered dietitian, nutrition researcher, and Assistant professor at NYU.

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Physician's Weekly

JUNE 11, 2025

The report found that the number of potential caregivers for an individual 80 or older will decrease significantly by 2050. The specialists help connect individuals with cognitive impairment to community resources, bolstering memory cafe attendance. “We all have a good time going around,” he added. I get to meet them.

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Physician's Weekly

JUNE 25, 2025

— Cedric Sturdevant woke up with “a bit of depression” but made it to church, as he does every Sunday. In a few days, he would drive from Mississippi to Washington, D.C., to join HIV advocates at an April rally against the Trump administration’s actions. About 40% of adults with HIV rely on it for their lifesaving treatments.

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GeriPal

APRIL 17, 2025

What a Wonderful World could be sung in irony at this moment. I hope we all take it literally, with the hope this podcast ends with. Alex Smith ** This podcast is not CME eligible. To learn more about CME for other GeriPal episodes, click here. Transcript Eric 00:00 Welcome to the GeriPal Podcast. It is a terrific book. Alex 02:07 Yeah, I love it.

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Physicians News Digest

APRIL 3, 2025

But neither Kennedy nor President Donald Trump have explained why individual agencies such as AHRQ were targeted for cuts or indicated whether any of their work would continue. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals.

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