The Clinical Problem Solvers

APRIL 24, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Hospital Appointment 52

FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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Patient-Centered Manufacturing Clinic Provider 52

PEMBlog

OCTOBER 26, 2023

“Clinically, Meckel diverticulum should be suspected in any child younger than 2 years of age with painless rectal bleeding. STAT Pearls, 2023 Wrap Up Meckel diverticulum is a congenital anomaly of the small intestine that can present with various clinical manifestations, including rectal bleeding and obstruction. .”

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Diagnosis Complication Consulting Management 64

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. Since then, the concept has become a reality.

Healthcare 64

Healthcare Hospital Medical Patient-Centered 64

FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. Fiscal Year 2023 showed similar performance.

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Consulting Manufacturing Utilities Provider 52

FDA Law Blog

JANUARY 30, 2025

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. However, the meaning of due diligence has long been a question.

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IT Clinic Provider Patients 105

FDA Law Blog

FEBRUARY 23, 2025

For example, in an October 13, 2023 WL to ReNovo, Inc., FDA also found that analytical sensitivity and precision testing provided by Abbott was inadequate to confirm the impact of such changes on the clinical performance of its device. This can limit the type of information that can be gained from WLs.

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Manufacturing Provider Consulting IT 64

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. What medical technologies could be ideal to transition to use in non-clinical settings?

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. Information about these typical non-clinical tests is generally based on previously released guidance documents for each topic, as linked above.

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Manufacturing Engineering Clinic Patients 45

FDA Law Blog

JANUARY 4, 2023

The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. The Agency stated that the most common reason for a clinical hold of a Phase 1 study under an investigational new drug (IND) is related to safety. before evaluating clinical effectiveness). Comparability.

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Manufacturing Engineering Clinic Provider 59

PEMBlog

SEPTEMBER 24, 2024

Pulmonology and surgery were consulted during his hospital stay, and he has since had a left lower lobectomy after healing from his pneumonia. Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2023 Jul 24. Treasure Island (FL): StatPearls Publishing; 2023 Jan–.

Diagnosis 52

Diagnosis Diagnose Patients Asthma 52

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., stroke).

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Patient-Centered Clinic Patients Provider 49

PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Always review the latest care plans, assess longitudinal trends in cardiac biomarkers, and consult with specialists when needed to ensure that each patient receives individualized and optimal care. Pediatrics.

Patients 52

Patients Complication Management Consulting 52

PEMBlog

SEPTEMBER 6, 2023

Clinical utility of screening laboratory tests in pediatric psychiatric patients presenting to the emergency department for medical clearance. Children requiring psychiatric consultation in the pediatric emergency Berg JS, Payne AS, Wayra T, Morrison S, Patel SJ. Hosp Pediatr (2023) 13 (1): 66–71 Health Aff (Millwood).

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

FDA Law Blog

FEBRUARY 1, 2022

Another commenter suggested that FDA limit listable patents only “to patents protecting innovations that improve health and have been demonstrated to do so through clinical testing.” Finally, several commenters addressed REMS. The Agency however has made no commitments—nor has it even hinted at—revising the Orange Book.

Provider 52

Provider IT Consulting Manufacturing 52

FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. Code § 64B16-27.810(1).

Insurance 52

Insurance Patients Utilities Chronic Condition 52

GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). AlexSmithMD 1. Beth, welcome to GeriPal. Beth: Thank you. Greg, welcome to GeriPal.

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Physician's Weekly

JUNE 19, 2025

On a gloomy Friday in January, Johnson, a nurse practitioner who treats older adults, had a hospice consult with Ellen, a patient in her 90s in declining health. The AMA points out that doctors must have more schooling and significantly more clinical experience than nurse practitioners. “Hello. How are you feeling?”

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

Today's Hospitalist

JUNE 7, 2025

They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” All anti-obesity medications, even the earlier generation of these drugs—which include orlistat, phentermine, phentermine/topiramate (Qsymia) and naltrexone/bupropion (Contrave)—cause clinically significant weight loss.

Hospital 66

Hospital Management Diabetes Patients 66

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. Is my sore throat contagious?

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ER Telehealth Primary Care Doctor Appointment 52

PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. Updated 2023 Jul 17]. On clinical presentation.

Consulting 59

Consulting Individual Families Family 59

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

Clinic 59

Clinic Provider Individual IT 59

GeriPal

JANUARY 16, 2025

I, for example, had one patient, I remember during my fellowship, I was in geriatrics clinic and had a very well read patient who came in and was reading a New York Times article, I think in the well section at one point. Alex 16:45 That really rings true with my clinical experience. Decision making hierarchies by default.

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Patient-Centered IT Patients Healthcare 109

FDA Law Blog

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

PEMBlog

JANUARY 16, 2025

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Clin Toxicol (Phila) 2023; 61:453. I would consult a toxicologist because I know that this is rare. Updated February 26, 2024.

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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IT Provider Patients Families 114

Physicians News Digest

MAY 12, 2025

31 that a New York physician had been indicted for shipping abortion medications to a woman in Louisiana, it stoked fear across the network of doctors and medical clinics who engage in similar work. The clinic doesn’t mail pills into states with bans, but it does treat patients who travel from those states to Maine for abortion care. “It

Telemedicine 52

Telemedicine Families Family Patients 52

PEMBlog

APRIL 4, 2025

Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. So as of the 2023-24 school year, about 3.3%

Vaccination 68

Vaccination Illness IT Clinic 68

GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. But in California where I practice medical aid and dying is legal and similar to other issues that are controversial in some places, many physicians do not prescribe or do visits for medical aid and dying consultations.

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Telemedicine Telehealth Patient-Centered Board-Certified 73