FDA Law Blog

JUNE 29, 2022

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. Rescinded . Sources: CDER BTD Requests and CDER BTD Rescissions.

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FDA Law Blog

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. 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.

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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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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. FDA Seeks Comments on Greater Patient Involvement in Medical Product Development (Nov.

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

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PEMBlog

JUNE 2, 2025

Secondary hypertension is the more common cause of the two and is related to renal, cardiac, pulmonary, oncologic, endocrine, or autoimmune pathologies, in addition to medication side effects. 3 mg/kg/hr; onset of action is less than 5 minutes, and the duration of medication lasts between 2-6 hours. Labetalol dosing: 0.2-1

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GeriPal

MARCH 2, 2023

It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. 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. Eric: Are these generic?

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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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The Clinical Problem Solvers

NOVEMBER 16, 2020

Medicine has never been an apolitical field, and understanding the specific ways the medical field contributed to socio-political definitions of race through practices rooted in medical racism can help us avoid repeating the same harms of the past (e.g. 2012 Sep;53(3):279-95. racial essentialism). link] Wilkerson, I.

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GeriPal

MARCH 7, 2024

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. There’s an organization that I took my training from, which began, I want to say, in 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.” Cocktail Medications. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 29, 2009)).

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GeriPal

AUGUST 1, 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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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. In 2017, Sturdevant returned home to the Mississippi Delta to launch a nonprofit, Community Health PIER , in one of the poorest and most medically underserved parts of the country.

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GeriPal

APRIL 17, 2025

You know, I’m thinking about, like, you know, I think, Eric, you served on our medical school admissions committee once. That looks at what the Baha’is have been doing since 2012. You know, some would have called that a DEI initiative, but it was an initiative towards excellence. It isn’t the only.

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Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Medical errors caused by missed diagnoses, drug errors, hospital infections, and other factors kill and maim tens of thousands of Americans each year. Kennedy Jr.

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