Annals of Family Medicine

NOVEMBER 20, 2024

Setting: Alberta, Canada from May 2022 to October 2023. We utilized theoretical constructs of salutogenesis – manageability, meaningfulness, and coherence; and resilience. We utilized theoretical constructs of salutogenesis – manageability, meaningfulness, and coherence; and resilience.

Healthcare 130

Healthcare Referral Provider Utilities 130

FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Medical 64

Medical Electronics Manufacturing Utilities 64

Barton Associates

JUNE 19, 2025

In fact, hospitals, clinics, and other facilities are already reeling from a shortage of providers and it’s hurting patients— according to the United States Department of Health and Human Services (HHS) , tens of millions of Americans live in areas with shortages of primary care, dental, and mental health professionals.

Healthcare 52

Healthcare Healthcare Professional Provider Community 52

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.”

Medical 111

Medical Clinic Patients IT 111

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.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

PEMBlog

OCTOBER 26, 2023

This nuclear medicine scan utilizes a radioactive tracer that is taken up by the gastric mucosa in Meckel’s diverticulum, thereby helping to identify its presence. “Clinically, Meckel diverticulum should be suspected in any child younger than 2 years of age with painless rectal bleeding. The bleeding is usually painless.

Diagnosis 64

Diagnosis Complication Consulting Management 64

FDA Law Blog

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. By the end of Q2 FY 2023, FDA will establish a committee including members from CDER and CBER to support implementation of the commitments in this section.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

FDA Law Blog

DECEMBER 11, 2023

In fact, as of November 2023, the CMS’s Standards and Certification’s (S&C’s) Quality, Certification and Oversight Reports (QCOR) CLIA Laboratory Lookup Database shows 17,206 CLIA-certified laboratories. We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

Clinic 64

Clinic IT Utilities Government 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.

Consulting 52

Consulting Manufacturing Utilities Provider 52

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

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).

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

PEMBlog

SEPTEMBER 6, 2023

Clinical utility of screening laboratory tests in pediatric psychiatric patients presenting to the emergency department for medical clearance. Hosp Pediatr (2023) 13 (1): 66–71 When should the emergency physician obtain lab tests to medically clear such patients? Health Aff (Millwood). 2015;34(5):812-818 Chun TH. Ann Emerg Med.

Lab Testing 52

Lab Testing Medical Patients Mental Health 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. By Larry K. 823(g)(1).

Insurance 52

Insurance Patients Utilities Chronic Condition 52

Physician's Weekly

JUNE 22, 2025

High social risk burden in adults with IBD drives emergency care use and medication gaps—spotlighting the urgent need for social screening in clinical practice. A greater social risk burden was linked to increased odds of unplanned healthcare utilization (severe vs none: OR, 3.5 [1.2-10.2])

Healthcare 52

Healthcare Transportation IT Insurance 52

FDA Law Blog

JANUARY 4, 2023

2617, the “ Consolidated Appropriations Act, 2023 ,” was signed into law by President Biden on December 29. The PIE Act, otherwise known as section 3630, “Facilitating Exchange of Product Information Prior to Approval” of H.R. Industry has grappled with interpreting this regulation – what is promotion? what is commercialization?

Patients 64

Patients Provider IT Utilities 64

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)). population demographics.

Clinic 59

Clinic Provider Individual IT 59

FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

Manufacturing 59

Manufacturing Utilities Provider IT 59

PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Updated 2023 Jul 17]. This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. References Jeanmonod R, Asuka E, Jeanmonod D.

Consulting 59

Consulting Individual Families Family 59

GeriPal

APRIL 6, 2023

-Alex Practice-PC Program Information: UCSF’s Practice-PC program is now accepting applications for the 2023-2024 year. Practice-PC is an intentionally interprofessional and cutting edge year-long group continuing education course in palliative care for working professionals from all disciplines, in the Bay Area. The theme is death.

IT 99

IT Patient-Centered Families Family 99

PEMBlog

APRIL 26, 2023

Listen Gun Violence and Safety (2023) – Brad Sobolewski, MD, MEd – featuring Kit Carney, MD & Kristen Humphrey, MD – PEM Currents: The Pediatric Emergency Medicine Podcast [link] Subscribe Advocacy and education resources Be SMART Campaign Be SMART emphasizes the importance of responsible gun ownership and secure gun storage.

Family 52

Family Families Mental Health Healthcare 52

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

JULY 13, 2023

Randy died February 26, 2023. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. They found a difference of 4% in documented goals of care discussions. Is 4% meaningful? Randy Curtis was first author of the JAMA paper. I think it’s you, Bob.

Patient-Centered 83

Patient-Centered IT Patients Hospital 83

GeriPal

DECEMBER 21, 2023

Summary Transcript Summary We’ve talked a lot about comprehensive dementia care on the GeriPal podcast but while the evidence is clear that these programs work, the uptake has been limited largely because there hasn’t been a strong financial case for it. It requires a fight. It’s been going on for many decades now. Malaz: I love it.

Patient-Centered 125

Patient-Centered IT Families Family 125

FDA Law Blog

JUNE 1, 2025

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

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. Start with a story as Carly did in her Op Ed. Stories trump data. Write to your congressperson. Before we do, I think, Joe, you have a song request for Alex. Joe: I do. Eric: Wait, which version? But not Space Oddity.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73