Family Medicine Initiative

APRIL 9, 2024

Yes, one year after stopping the medication, patients regain ½ – ⅔ of their previous weight loss: What are other clinical benefits? In March 2024, FDA therefore approved semaglutide for secondary CVD prevention in overweight or obese adults. Tirzepatide (15 mg) showed slightly more noticeable effects than Semaglutide (2.4

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FDA Law Blog

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). They also present a more intense focus on the timelines for confirmatory study initiation and completion as well as the feasibility of those studies to verify clinical benefit within those timelines.

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FDA Law Blog

FEBRUARY 2, 2024

Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). By Steven J. Gonzalez & Allyson B. First, all this would do is move the premarket submission from one bucket to another.

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Sound Physicians

NOVEMBER 19, 2024

I am often asked about how Sound builds the next generation of clinical leaders. It is, by design, built into the ways we educate, train, and support our clinical leadership. Emerging Leaders Dr. Charles Charman, medical director and overseer of the Emerging Leaders program, presents at the 2024 EmLe cohort session at MDS.

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FDA Law

JUNE 18, 2025

With the available information, a product undesignated voucher would seem to provide the most flexibility and allow companies to pivot from one program to another in the event of unforeseen circumstances, such as ambiguous clinical trial results or problems with a manufacturing facility. Easily interpreted clinical trial endpoints (e.g.,

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FDA Law Blog

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed.

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Physician's Weekly

JUNE 24, 2025

This is a well-done and concise summary of where we are in 2024 in trying to tackle the immense public health problem of MASLD.” Fontana, MD , who was not involved in the Metabolism study, tells Physician’s Weekly ( PW ). PW: Why was it important to do this study? PW: How may this summary affect patient care?

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Minnesota Academy of Family Physicians

FEBRUARY 20, 2025

The Minnesota Academy of Family Physicians (MAFP) adopted a resolution (policy guidance) in 2024 related to addressing food insecurity in Minnesota. An excerpt follows: 2024-04. Encourage Healthy Eating Through Vouchers: Many clinics and systems have voucher programs in place to help supplement food for patients.

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FDA Law Blog

JUNE 2, 2025

RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Importantly, FDA did not say that sales to customers who are doing exclusively clinical diagnostics, alone, formed the basis of the agencys letter. RUO certification programs were something that FDA had, at one time, recommended.

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Today's Hospitalist

MAY 9, 2025

Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation. This isn’t about replacing your clinical judgment. Ambient dictation, or ambient clinical documentation, represents a paradigm shift. This isn’t about replacing your clinical judgment.

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Physician's Weekly

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. A 2024 study published in the journal Nature Medicine found that military veterans with brain injuries saw major mental and physical improvements after just one ibogaine session.

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Permanente Medicine

APRIL 16, 2025

Both groups have a shared mission of delivering high-quality, cost-efficient care that achieves superior clinical outcomes. By collaborating clinically, sharing innovations, and supporting physicians and staff, NWP will improve quality of care. Kaiser Permanente in Northern California received 4.5

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Barton Associates

MAY 29, 2025

News & World Report in 2024 , the unemployment rate for physicians is 0.3%, which is less than the national unemployment rate of 4.2% Editor’s Note: This blog was originally published in February 2024 by Mike Connors and was updated in May 2025 by MIke Connors to reflect new information. in April 2025.

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The Medical Futurist

MAY 18, 2025

Clinical use is already accepted, new FDA approvals and new trials are underway targeting new niches, like pediatric surgeries. They have started a large-scale clinical trial involving 10,000 patients, expected to last two years, with plans to obtain CE marking by the end of 2024. But there is undoubtedly impressive progress.

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Physician's Weekly

JUNE 11, 2025

The r/Hidradenitis subreddit is an actively growing community that boasts 40,485 subscribers as of August 2024. The researchers emphasized the forum’s role as a vibrant peer-support network but noted their findings also highlight areas where clinical communication may be falling short.

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Education Patients Management Patient-Centered 52

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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FDA Law Blog

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. Specifically, OPDP alleges the ad implies that UBRELVY quickly eliminates migraine pain after just one dose, which was not fully supported by clinical data.

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PEMBlog

SEPTEMBER 26, 2024

Clinical presentation can include subperiosteal bone hyperplasia, swelling of the overlying soft tissue as well as associated fever and irritability. In addition, congenital syphilis will have other clinical manifestations including cutaneous lesions, jaundice, anemia, and snuffles. It most often affects the mandible and long bones.

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PEMBlog

SEPTEMBER 25, 2024

Accessed June 18, 2024. Accessed June 18, 2024. Accessed June 18, 2024. Accessed June 20, 2024. Topical Losartan: Practical Guidance for Clinical Trials in the Prevention and Treatment of Corneal Scarring Fibrosis and Other Eye Diseases and Disorders. It took two months for the patient to completely recover.

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Logansport Memorial Hospital

MARCH 4, 2024

Logansport Memorial Hospital is pleased to announce the opening of a new pain management center on April 1, 2024. We have a strong need for pain management services in our community and opening this clinic will allow our patients to have convenient access to high quality, safe treatment methods for chronic pain.”

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Management Patient-Centered Community Referral 52

FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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The Physicians Foundation

AUGUST 15, 2024

is honored for his transformative work, connecting patients with primary care and critical health resources BOSTON, August 15, 2024 – The Physicians Foundation is proud to announce Jubril Oyeyemi, M.D., In July 2024, The Physicians Foundation also honored E. Jubril Oyeyemi, M.D., president of The Physicians Foundation. As the U.S.

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FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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PEMBlog

MARCH 4, 2025

Well cover its clinical presentation, epidemiology, diagnostic approach, and management, including why standard beta-lactam antibiotics wont work. Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations.

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FDA Law Blog

JULY 17, 2024

Earlier this month the FDA announced the first meeting of the GeMDAC will be held on August 2, 2024 to discuss a novel treatment for Niemann-Pick disease type C (and Frank and James are looking forward to being there!). By Sarah Wicks & James E. Valentine & Frank J.

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Myriad Genetics

APRIL 15, 2024

Mayo Clinic. Accessed February 22, 2024. Published April 16, 2024. Such is the case with the 22q11.2 microdeletion syndrome, a relatively common and potentially serious chromosomal abnormality. 2 Maternal age does not affect the likelihood of the 22q microdeletion. The annual incidence of DiGeorge/velocardiofacial syndrome. 

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FDA Law Blog

OCTOBER 14, 2024

Gonzalez — On September 27, 2024, in U.S. The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Stem Cell Clinic, LLC , 998 F.3d

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Clinic Patient-Centered Asthma Patients 59

Permanente Medicine

MAY 22, 2025

As chief quality officer at The Permanente Federation, Dr. Bridges oversees coordination of national clinical quality care programs across Kaiser Permanente for its 12.6 Visionary physician leader to oversee national coordinated efforts that support and advance Kaiser Permanente’s acclaimed levels of high-quality care OAKLAND, Calif.,

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FDA Law Blog

FEBRUARY 28, 2024

As the approval was granted using the accelerated approval pathway, the approval was subject to a postmarketing requirement to verify and describe the clinical benefit of the drug in a Phase 3 trial. FDA has not yet published draft guidance; however, the statutory deadline to do so is June 2024. Tobolowsky & Michelle L.

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FDA Law Blog

OCTOBER 16, 2023

Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there. Javitt & Steven J. demographic bias of data fed to algorithms).

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FDA Law Blog

JULY 23, 2024

The draft guidance (June 2024) defines an EDDO as the “design outputs necessary to ensure delivery of the intended drug dose to the intended delivery site. Comments may be submitted by September 30, 2024. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

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Physician's Weekly

JUNE 24, 2025

As data from the 2024-25 season becomes available, researchers hope to determine whether the vaccine will remain a one-and-done, or whether immunity will require repeated vaccination. Her doctor and several pharmacies turned her down because she was below the recommended age at the time, which was 60.

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Sound Physicians

NOVEMBER 5, 2024

Sound Critical Care is at the forefront of bringing coordinated leadership and clinical excellence to hospital ICUs and the patients within them. For hospitals, this means investing in cutting-edge medical interventions and partnerships that help them transition to the modern best-practice of dedicated ICU management.

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PEMBlog

SEPTEMBER 24, 2024

Most patients are afebrile by the third day of treatment and clinically improved within two weeks. The CT also showed normal pulmonary venous return via the left lower pulmonary vein. Additionally, the CT revealed findings most consistent with necrotizing pneumonia within the sequestered portion of the lung and a small left pleural effusion.

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Sound Physicians

OCTOBER 30, 2024

Osman Saleem, Medical Director for our hospital medicine practice at Mercy Hospital of Buffalo in Buffalo, New York, to go behind the stethoscope and learn more about how he came to Sound and his leadership journey:    When did you first consider a career in medicine? It was my job to work back to that program and gain that respect back.

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PEMBlog

MAY 1, 2025

In this episode, we tackle the clinical mischief of Parvovirus B19 , a common viral infection with a surprisingly wide range of manifestationsfrom the classic slapped cheek rash of erythema infectiosum to aplastic crises in children with hemolytic anemias and fetal hydrops in pregnant contacts. UpToDate , Jun. link] Edwards, Morven S.

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Complication Patient-Centered Patients Clinic 86

FDA Law Blog

JUNE 3, 2025

DEAs position is contrary to statements made in the agencys 2024 Coconut Grove decision when its expert opined at the hearing that filling immediate-release opioids prescribed and dispensed over a period of one and a half to two years presented red flags and [the pharmacy] needed to properly resolve these red flags before dispensing.

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