Medical Xpress

MARCH 1, 2023

Since its approval in 2012, HIV pre-exposure prophylaxis, or PrEP, has shown promise in reducing HIV infection rates by preventing infection in high-risk HIV-negative people. However, research shows that only around three percent of sexual and gender minority (SGM) adolescents who are eligible for PrEP have used it.

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The Clinical Problem Solvers

MAY 9, 2021

However it is important to remember that this political invention DOES affect biology because of the way that it creates social inequity. Historical Context: Historically, laws such as interracial marriage bans have protected established structures of white supremacy and reinforced the social construct of race.

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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. Complaint, 82. 81, 86, 251.

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Reflections of a Grady Doctor

JULY 30, 2019

This medical student looked like me. Just like that ultra ordinary day in Jury Duty back in 2012. “And who knows but that you have come to your royal position for such a time as this?” - Esther 4:14 NIV A door had closed before her. It seemed like there was no way out. Some way, somehow our paths crossed. And that was when I knew.

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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). For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor.

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. According to the Medical Device Databases webpage, the De Novo database is to be updated weekly.

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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

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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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 21, 2022

From 1997 to 2003, Dr. Unger served as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (“CBER”). Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012.

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PEMBlog

MAY 11, 2023

And what about the J-Tip, a device that uses pressurized gas to send medication into the subcutaneous portion of the skin – deeper than topical anesthetics? 2012 Jul;28(7):687-90. This helps to open up the spaces between the vertebrae and makes it easier for the needle to enter. What about topical anesthetics? Pediatr Emerg Care.

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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

(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

FEBRUARY 27, 2024

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. § Absent a convincing showing, the Office after considering all of Applicant’s argument plans to issue only one PTE directed to ZYDELIG® (idelalisib). l 56(c)(4) and 37 C.F.R.

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The Health Policy Exchange

MARCH 14, 2013

In this month's Georgetown University Health Policy seminar, we discussed the financial and political challenges that AHRQ and its predecessor, the Agency for Health Care Policy and Research (AHCPR) have faced while trying to improve outcomes and effectiveness of medical care since the latter's founding during the first Bush Administration.

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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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Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group.

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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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FDA Law Blog

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. The FDA Reauthorization Act of 2017 (FDARA) directed FDA to develop guidance to enhance diversity in clinical trials. FDORA further directed FDA to issue guidance on the format and content of DAPs.

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FDA Law Blog

JUNE 7, 2021

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. This has been a decision we’ve been closely following. Key Takeaways from the Aduhelm Label: What’s in It and What Isn’t.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context Human papillomavirus (HPV) is a common sexually transmitted infection that can lead to multiple types of cancer. HPV vaccination is recommended for all children starting at age nine years, and it is most effective before HPV exposure. It remains uncertain how ethnicity and country of birth relate to HPV vaccination among younger Latinos.

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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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PEMBlog

MAY 24, 2023

For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Berzlanovich AM, Schöpfer J, Keil W. 2012 Jan;109(3):27-32. 2012 Feb;13(1):35-40. PMC3272587.

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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. Edwin Lindo 03:28 ​What is race? How is race a social construct? For genetics?

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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. But before we jump into that topic, John, do you have the song request for Alex? John: I do.

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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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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

MARCH 20, 2025

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

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PEMBlog

JUNE 5, 2024

2012 Jan 13;61(RR-1):1-20. Cervical Spine Injuries are fortunately rare in children. this episode is all about learning when to suspect them, how to immobilize the C-spine properly, and which imaging test to choose. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011.

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FDA Law Blog

FEBRUARY 4, 2025

This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed. Our colleagues have recently blogged about the RPD PRV here and here , its four-year sunset date, and the political drama that it frequently gets caught in.

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PEMBlog

APRIL 26, 2023

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. Melzer-Lange, Joseph O’Neil, Wendy J. Pomerantz, Elizabeth C. Powell, Seth J. Scholer, Gary A. Smith; Firearm-Related Injuries Affecting the Pediatric Population.

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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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Common Sense Family Doctor

MARCH 23, 2025

Please join me and hundreds of medical organizations in standing with AHRQ and preserving its vital contributions to the health of all Americans. ** For the past 30 years, a little-known U.S. Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency.

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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

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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