The Clinical Problem Solvers

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2023 Apr;21(2):166-7.

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PEMBlog

SEPTEMBER 6, 2023

When should the emergency physician obtain lab tests to medically clear such patients? Also, while evidence for lab evaluation based on history and exam findings was established for adults, children were considered to have a medical etiology (organic psychosis) until proven otherwise. Acute onset psychosis is relatively rare.

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Lab Testing Medical Patients Mental Health 52

FDA Law

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

FDA Law

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. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), next week, on December 6-7, 2023. HPM”), as well as other experts from FDA, DOJ, and the private sector.

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FDA Law

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released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023.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. By Adrienne R.

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Consulting Manufacturing Utilities Provider 52

The Clinical Problem Solvers

APRIL 24, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2023 Apr;21(2):166-7. Benton TD.

Mental Health 52

Mental Health Community Hospital Appointment 52

FDA Law

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023.

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Clinic IT Patient-Centered Consulting 111

FDA Law

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

IT 52

IT Consulting Manufacturing Provider 52

FDA Law

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Democratic senators also weighed in, supporting rescheduling to schedule III in December 2023. Whether DEA is consulting the Department of State about treaty obligations regarding marijuana and diplomatic implications of rescheduling?

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Manufacturing Consulting IT Individual 59

FDA Law

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame. Sometimes, though, the question of classification defies an easy answer.

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Provider IT Consulting Utilities 69

FDA Law

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. citizens, including green card holders, must follow additional steps, so consult with your lead reviewer for guidance.

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Screening Transportation Provider Electronics 59

FDA Law

JANUARY 30, 2025

In its new guidances, FDA advises that sponsors should consult with the Agency regarding confirmatory trial design and conduct as early as possible with enough time to allow the trial to be underway at the time of approval. However, the meaning of due diligence has long been a question.

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IT Clinic Provider Patients 105

FDA Law

FEBRUARY 23, 2025

For example, in an October 13, 2023 WL to ReNovo, Inc., Thus, when evaluating your next set of device changes and whether a new 510(k) is needed, you may want to consult a third-party database (or an advisor that has access to such a database) to help with this search.

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Manufacturing Provider Consulting IT 64

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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Manufacturing Engineering Clinic Patients 45

FDA Law

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. 21 C.F.R. §§ 1306.04(a),

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Insurance Patients Utilities Chronic Condition 52

FDA Law

APRIL 23, 2023

Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., Tobolowsky & David B. Sponsors should also propose additional analyses to evaluate the comparability between the trial arms for important covariates.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

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. Beth: Yeah.

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Board-Certified IT Primary Care Referral 110

Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. She keeps them informed of subtle changes, such as whether a person was verbal and eating and whether their medical conditions have changed.

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Nurse Practitioner Family Families Primary Care 52

Today's Hospitalist

JUNE 7, 2025

Because many medications can cause weight gain, doctors should consider more weight-neutral alternatives. Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. These medications are truly life-changing for many patients.” Nor should they be.

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Hospital Management Diabetes Patients 66

Doctor On Demand

APRIL 28, 2025

Here’s a closer look at the red-flag symptoms that signal it’s time to visit urgent care for a sore throat: Severe sore throat or trouble swallowing A severe sore throat or trouble swallowing suggests you might have a more complex underlying cause needing urgent medical attention. These symptoms require immediate medical attention.

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ER Telehealth Primary Care Doctor Appointment 52

Physician's Weekly

JUNE 19, 2025

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. When Bob changed jobs, the price tag for his daughter’s medication went through the roof. They started trying out different medications and dosages.

Insurance 52

Insurance IT Board-Certified Medical 52

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. So medication adjustments.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions.

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Patient-Centered IT Patients Healthcare 109

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Updated 2023 Jul 17]. No, I’m not.

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Consulting Individual Family Families 59

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

Clinic 59

Clinic Provider Individual IT 59

PEMBlog

JANUARY 16, 2025

Clin Toxicol (Phila) 2023; 61:453. Its evolved from its medical and industrial applications to a recreational substance with a significant cultural footprint. I would consult a toxicologist because I know that this is rare. Updated February 26, 2024. Accessed January 13, 2025. link] Hogge RL, Spiller HA, Kistamgari S, et al.

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Complication Patient-Centered Management Patients 52

FDA Law

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

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Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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Healthcare IT Community Illness 100

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. Reading Ira’s article, it essentially was the VITAS Medical Director job description.

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IT Provider Patients Family 113

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Sources: Medical News Today [link] Oregon State University [link] BistroMD [link] Health line [link] Integrated Institute of Nutrition [link] Nutritious Life [link] Tags: Fort Mill wellness Goals Diets whole foods healthy eating Recent Posts See All Join Our Wellness Program! Learn more.","robots":"index","keywords":"skin

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Referral Family Medicine DO Primary Care 40

GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. But one of the things I worry about, when we really know medically where this case is going and we find, how many times has this happened?

Patients 98

Patients IT Patient-Centered Hospital 98

FDA Law

JUNE 10, 2025

The agency revised the list in October 2023 when it added twenty-eight chemicals, removed two List I chemicals automatically included as a laboratory supply and added “tableting machines, including punches and dies.” One commenter, without providing details, asserted that the chemical may have uses in the medical field. at 23,478-79.

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Specialization Manufacturing Electronics PCP 69

FDA Law

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. And so in November 2023 in St. The robust discussion that day in November 2023 is now captured in an APIIC report announced this week , titled “ A Bold Goal: Reshoring 25% of Small Molecule API to the U.S.

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Supply Chain Manufacturing Government Provider 69

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 indictment also sparked worry among abortion providers like Kohar Der Simonian, medical director for Maine Family Planning.

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Telemedicine Family Families Patients 52

PEMBlog

APRIL 4, 2025

So as of the 2023-24 school year, about 3.3% 2023 translates to about 80,000 kids in the United States, and vaccination coverage varies across states. So in the 2023-24 school year. So serious bacterial infection defined as any bacterial infection requiring medical intervention, but it may not invade sterile sites.

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Vaccination Illness IT Clinic 66