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. 81, 86, 251. 81, 89, 251.

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Individual Patients Provider Medical 64

FDA Law Blog

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

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Manufacturing Management IT Medical 105

The Clinical Problem Solvers

MAY 9, 2021

Rather than searching for obscure explanations for inequalities, we must instead recognize the ways that racism impedes health at both individual and structural levels. The New Press: 2012. The Clinical Problem Solvers Podcast. December 17, 2020. The problem with race-based medicine.” TEDMED 2015. Link to talk. Roberts DE.

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Hypertension Clinic Patients IT 52

FDA Law Blog

JUNE 29, 2022

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). The intent may be to leave that to the individual Centers to describe as they now do, but it would be helpful to include a statement to that effect in the Draft Guidance. Rescinded .

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IT Clinic Provider Medical 52

PEMBlog

MAY 1, 2025

Only about 25% of infected individuals will have this classic rash syndrome. One review identified about 129 cases of parvovirus-related neurologic complications between 1970 and 2012, with encephalitis making up about two-thirds of those cases. By the time the rash appears, viremia has resolved and the patient usually feels well.

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Complication Patient-Centered Patients Clinic 86

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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Manufacturing Supply Chain Provider Treatment Plan 59

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. Individuals with moral injury may see themselves and the world as immoral and irreparable. So why are physicians experiencing physical and mental collapse from overwork? Not burnout.

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Medical Student Diagnosis Physicals Medical 246

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. sections l56(a)(5) and 156(f)(1). l56(d)(1).

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Patients IT Provider Individual 59

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.

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Patients Patient-Centered Clinic IT 52

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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Management Referral Mental Health Community 52

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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Hypertension Management Physicals Lab Testing 75

GeriPal

MARCH 2, 2023

I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65. There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. Nisha: Both of them are generic, yeah.

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Patient-Centered IT Healthcare Medical 96

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. 2012 Sep;53(3):279-95. Acknowledging this truth highlights the necessity of mitigating the harms of racism as part of any comprehensive treatment plan. Institute for Healing & Justice in Medicine​; 2020.

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Clinical Practice Clinic Medical IT 52

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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Supply Chain Manufacturing Government Hospital 59

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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PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. Well, they could use lasers or cold steel or microdebridement, and it’s really tailored to the individual patient’s anatomy. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: [link] Hartl TT, Chadha NK. A systematic review of laryngomalacia and acid reflux.

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Diagnosis IT Diagnose Patients 52

GeriPal

MARCH 7, 2024

There’s an organization that I took my training from, which began, I want to say, in 2012. It sets space between us and the individuals we’re trying to take care of. The role is defined by the individual of what they need and I found that to be the biggest difference. It’s been around for a while. That works.

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Provider Illness IT Healthcare 117

GeriPal

AUGUST 1, 2024

And for any, any diet, it can, we can really tweak it to an individual’s preferences, their needs, that kind of thing. Emily 32:08 So studies out of rush have been coming out about this, and Martha Claire Morris has been talking about the mind diet now for, I think, since, like, 2012. What was the title of the book again?

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IT Diabetes Chronic Disease Patient-Centered 116

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. from an estimated 6.9 million people by 2060.

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Patients Families Family Diagnosis 52

Physician's Weekly

JUNE 25, 2025

In 2012, the CDC expanded its in-depth surveys to learn more about the lives of people at risk of HIV and of those with HIV who weren’t virally suppressed. He has taken on the role of dad or uncle to many. “We called ourselves the family of love,” he said.

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Government Community Family Families 52

GeriPal

APRIL 17, 2025

That looks at what the Baha’is have been doing since 2012. We have to understand that humanity is going through a process that is, you could say, organic and analogous to the stages of the individual human person. One is the history of racial advocacy and amity and unity. And then we have to look at constructive programs.

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IT Community Government Management 70

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. Cases of jaundice-related brain damage declined from 7 per 100,000 to about 2 per 100,000 newborns from 1997 to 2012. Despite spending $1.9

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