FDA Law Blog

JULY 17, 2024

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

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Common Sense Family Doctor

FEBRUARY 28, 2025

Family physicians are being squeezed by two accelerating trends: (1) too few of us to care for the growing US population and (2) the rising number of tasks that we are asked to accomplish for each patient. hours per day, with more than one-half of that time (14.1 hours) allocated to preventive care. hours) allocated to preventive care.

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Common Sense Family Doctor

DECEMBER 27, 2024

" The Gilded Age of Medicine is Here ," announced the title of a recent New Yorker article about the tactics of private equity firms that provide infusions of cash to struggling hospitals in order to extract hundreds of millions of dollars in profits by slashing costs to the bone and endangering the health of patients.

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Permanente Medicine

MAY 22, 2025

As an experienced physician leader, she is known for always going the extra mile for our patients and colleagues. ” Dr. She has held a variety of leadership positions within the organization dedicated to maintaining and advancing high-quality care that delivers value and superior outcomes for patients. million members.

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Myriad Genetics

APRIL 15, 2024

4 In a recent presentation, Dale Muzzey, PhD, Chief Scientific Officer at Myriad, summarized the findings this way: “We followed up with providers regarding their patients who screened positive for 22q. 5 Clear Benefits for Healthcare Providers and Patients The benefits to a high PPV are, well, myriad. Such is the case with the 22q11.2

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Physician's Weekly

JUNE 24, 2025

On June 9, Kennedy fired a panel of scientific advisers to the Centers for Disease Control and Prevention, and later replaced them with some who have been skeptical of vaccines. Immunocompromised patients, despite having a somewhat lower level of protection from the vaccine, will also benefit from it, Terebuh said. Kennedy Jr.,

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Today's Hospitalist

MAY 9, 2025

For many of us, the emergence of medical scribes, both in-person and remote, provided a valuable solution, offloading documentation and allowing us to have more focused patient interactions. It can differentiate between a physician’s questions and a patient’s responses and even filter out non-relevant small talk.

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PEMBlog

SEPTEMBER 25, 2024

Niharika Goparaju Pediatric Emergency Medicine Fellow at the University of Texas – Austin | Dell Children’s Medical Center Instagram: @ngoparaj, @atxpemsquad, @dellmedschool, @cat_yee Co-author: Catherine Yee, MD The Case A 12-year-old male with trisomy 21 presents with one week of right eye swelling and three days of clear eye drainage.

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FDA Law Blog

OCTOBER 16, 2023

In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

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ABIM

JUNE 17, 2025

She is currently Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center. And it also required a trip to a test center where I spent the entire day. I figured if it didn’t work out, I could always take the traditional, 10-year MOC exam the following year.

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PEMBlog

SEPTEMBER 26, 2024

Inbar Plaut PEM Fellow at UMASS Chan Medical School | UMASS Memorial Children’s Medical Center IG handle(s): @inbar.y, @umasspem Co-author: Zachary Binder The Case A 2-month-old male presents with 2-days of reluctance to move the right lower extremity. It most often affects the mandible and long bones. References Glorieux FH.

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PEMBlog

MARCH 4, 2025

Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations. 2024, www.uptodate.com/contents/mycoplasma-pneumoniae-infection-in-children. 2024 Dec;56(1):2386636. Epub 2024 Aug 3. UpToDate , 1 Nov.

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ABIM

JUNE 12, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. In 2024, 75% of ABIM Board Certified geriatricians who chose an assessment opted for the LKA, while 68% of ABFM geriatricians chose the LKA. Community Practice in ABIM Governance* Erica N.

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The Physicians Foundation

JANUARY 28, 2025

The Foundation’s recent survey found that while nearly all physicians agree that their patients’ health outcomes are affected by DOH, many physicians face challenges in addressing them. Expand Leadership Skills: The fellow will learn how to be a voice for change around physician-led solutions to address patients’ DOH.

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FDA Law Blog

JANUARY 13, 2025

Failure to list coconut as an allergen has also been mentioned in several warning letters (see, e.g., here ) and as the reason for several product recalls, including a recent Class I recall in April 2024 (see also, e.g., Class II recalls in 2018 and 2022 for listing coconut as an ingredient but failing to disclose coconut in the allergen statement).

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Priority Physicians

JANUARY 20, 2025

But if you’re a patient of a direct primary care (DPC) practice , you don’t need to guess about orthopedic pain management. Unfortunately, traditional care doctors often resort to the two easiest options for patients with joint or back pain: They send the patient for imaging or refer them to a specialist.

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FDA Law Blog

JUNE 3, 2025

We noted that the Drug Enforcement Administration (DEA) had explained in its 2021 Gulf Med Pharmacy decision that prescribing red flags do not prohibit pharmacies from filling a prescription but are potential signs of diversion or risks to patient harm that pharmacists must resolve before filling. 50,372, 50,375, (June 13, 2024).

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AMMD

FEBRUARY 14, 2025

In 2024, I had another scare. This is why conventional physicians treat DCIS in patients with surgery, radiation, and sometimes chemotherapy. There are also the luminal epithelial cells closest to the center. The center of the duct remains open to allow milk to pass through. Instead, it tends to stay local (3).

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PEMBlog

MAY 20, 2025

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. 2024-066854. 2024-066855.

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PEMBlog

MAY 1, 2025

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. Centers for Disease Control and Prevention. UpToDate , Jun. link] Edwards, Morven S.

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Complication Patient-Centered Patients Clinic 83

California Academy of Family Physicians (CAFP)

MAY 14, 2025

Elimination of (State-Only) Prospective Payment System Rates to Federally Qualified Health Centers and Rural Health Clinics for Undocumented Immigrants – Eliminates Prospective Payment System rates to clinics for state-only-funded services provided to undocumented Individuals.

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GeriPal

JANUARY 23, 2025

Today, we explore four fascinating studies highlighting innovative approaches to reducing medication use and improving patient outcomes. Patients received brochures detailing the risks of gabapentinoids, nonpharmacologic alternatives, and a proposed deprescribing regimen (see here for the brochure ). in the usual care group.

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Priority Physicians

JANUARY 27, 2025

Find a caring primary care doctor: As a direct primary care physician, I devote time to sit down with patients and learn about their lifestyles, hopes, desires, worries, and concerns. We all want to know how to stop fearing the future. Although anxiety appears to be the new malady du jour , much of it is natural and normal.

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ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. In 2024, 82% of ABIM Board Certified rheumatologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. The following is a summary report of the spring meeting.

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GeriPal

JUNE 20, 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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FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). It was also helpful to hear first-hand the practical challenges companies navigate in bringing products to market.

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PEMBlog

AUGUST 20, 2024

While ECPR shows promise in improving survival rates, particularly in pediatric patients with conditions like congenital heart disease, it is resource-intensive and carries significant risks. Now, some centers are using 15 minutes in their guidelines, but 30 is what I’m familiar with. 2022; 68:133–152. cardiac rhythms.

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FDA Law Blog

OCTOBER 14, 2024

Gonzalez — On September 27, 2024, in U.S. California Stem Cell Treatment Center, Inc., The resulting SVF is then administered to the same patient by injection, intravenous drip, or inhalation. By Steven J. Defendants may also seek en banc review of the decision from the full Ninth Circuit.

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FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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FDA Law Blog

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants. Bills are pending in other states, including Missouri and New York.

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Priority Physicians

FEBRUARY 3, 2025

Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice. " (Required) " indicates required fields Email (Required)   blog | careers | newsletter | Notice of Privacy Practices | privacy policy   © 2024 priority physicians, inc. What Does THC Do?

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FDA Law Blog

APRIL 13, 2025

LYTGOBI was granted accelerated approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusions or rearrangements. Join us as we break down what went wrong this time. What Happened? As a single-arm trial (i.e.,

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

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FDA Law Blog

JULY 17, 2022

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. For example, the October 1, 2025 report will contain claims for 2Q 2024 through 1Q 2025, plus lagged claims from 2Q 2023 through 1Q 2024.

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FDA Law Blog

OCTOBER 6, 2023

However, meeting this timeline would require FDA to issue a final rule within approximately six months of the PR’s publication date—in other words, by April 2024. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. until FDA completes its review of the application.”

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FDA Law Blog

FEBRUARY 29, 2024

FDA’s February 23, 2024 decision says that “the grounds for withdrawing approval have been met because: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use.

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Aspiring Minority Doctor

DECEMBER 31, 2024

So with that being said, and today being New Year’s Eve, I'm going to use this post to give a recap of 2024 :) January During my last post, I was in Orlando, Florida completing my pediatric craniofacial and plastic surgery months. January was a continuation of my Orlando experience with Pediatric Surgery. I had definitely been missing out!

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