The Clinical Problem Solvers

SEPTEMBER 28, 2019

Dr.’s Vivek Murthy, Bridget O’Brien, and Gurpreet Dhaliwal sought to answer this question in a 2018 study. From these conversations, they identified four general “themes”: (1) consistent learning efforts, (2) rigorous skills development, (3) developing “habits of the mind,” and (4) seeking out clinically rich working environments.

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Lab Testing Clinic Education Clinical Practice 52

Reflections of a Grady Doctor

APRIL 24, 2019

I took the interview there only because it coincided with my interview at The Cleveland Clinic. What happens to a dream deferred? Does it dry up like a raisin in the sun? Or fester like a sore— And then run? Does it stink like rotten meat? Or crust and sugar over— like a syrupy sweet? Maybe it just sags like a heavy load. Or does it explode?

Medical Student 52

Medical Student Internal Medicine Medical IT 52

Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Watchful waiting refers to clinical observation only. in 2000 to 59.8%

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Routine Screenings Screening Complication Diagnose 52

The Clinical Problem Solvers

OCTOBER 18, 2022

Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings. Heard-Garris draws parallels between the culture within the carceral system and that within hospitals and clinics.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

My Green Doctor

APRIL 4, 2025

from 2000 to 2018 among people over 65 years old. It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. Encourage Small Changes That Add Up Shift your clinic toward paperless records and LED lighting to reduce waste and energy costs.

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Healthcare Professional Healthcare Community Medical Advice 52

FDA Law Blog

FEBRUARY 16, 2022

In 2009, Catalyst’s drug Firdapse (amifampridine phosphate) received Orphan Drug Designation for Lambert-Eaton Myasthenic Syndrome (“LEMS”), and FDA subsequently approved Firdapse in November 2018 for the treatment of LEMS in adults with 7 years of Orphan Drug Exclusivity.

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FDA Law Blog

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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PEMBlog

OCTOBER 31, 2024

2018 Nov 22;379(21):2002-2014. N Engl J Med 2018; 379:2015-2026. There were also no differences in the duration of diarrhea or vomiting, day-care absenteeism, or household transmission of symptoms. Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts.

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Hospital Illness Patients Provider 105

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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FDA Law Blog

AUGUST 12, 2021

Biosimilars do provide a more affordable way for sponsors to get products onto the market—by referencing the clinical studies performed by the reference product sponsor—which, in theory, allows for the introduction of lower cost versions of expensive biologics. As FDA states in its Press Release, “Biosimilars marketed in the U.S.

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FDA Law Blog

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

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Diagnosis Clinic Provider IT 59

FDA Law Blog

JANUARY 15, 2024

FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting.

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The Clinical Problem Solvers

JANUARY 18, 2021

1:05:57 Outtakes Takeaways Name Racism for What It Is If we don’t explicitly say the word racism, and identify its historical context, then we are complicit in its denial. Racism denial is deeply ingrained in our society and it needs to be called out and recognized as a system in order to be addressed. References Mentioned 01:55 Jones, C.

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Community Medical Individual IT 52

FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

AUGUST 4, 2022

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022.

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Manufacturing Medical Government IT 98

GeriPal

MAY 19, 2022

It depends on the clinical situation. Summary Transcript Summary. A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). How do you do that? Do you do what I do, pull out a handy-dandy opioid equianalgesic table to give you a guide on how much to convert to? . Oh boy, what should we do?

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IT Patients Individual Relationship 139

Aspiring Minority Doctor

DECEMBER 8, 2021

I also love wearing my Medelita Kinetic Scrub Jacket especially since the hospitals and clinics are so cold. ProCompression Socks Throwback pic from one of my 2018-2019 24hr call shifts I swear by Pro Compression socks! Happy December! Can you believe Christmas is only 17 days away?!?! Plus they smell amazing!

Electronics 52

Electronics Healthcare Professional IT Medical Student 52

33 Charts

FEBRUARY 24, 2022

It comes from Automattic engineer Mike Shelton in 2018. Industrialized healthcare positions patients as units in clinical workflows. If you like The People Margin you might like our Clinical Industrialization Archives. I love this concept of the people margin. Shelton wasn’t talking about medicine but he could have been.

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Engineering Healthcare Clinic IT 45

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. Comments may be submitted until February 7, 2022.

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Medical Manufacturing Healthcare Government 98

PEMBlog

APRIL 22, 2025

The Journal of Clinical Psychiatry. 2018 May/Jun;79(3):17r11506. Work with your hospitals care coordination team to create pathways for kids with recurrent ED visits. Advocate for transition planning resources as patients age out of pediatric care. As Nicholas et al. Pediatric Emergency Care. 2022;38(7):332-336. doi:10.1097/PEC.0000000000002751.

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Family Families Patient-Centered Physicals 80

FDA Law Blog

DECEMBER 16, 2024

All proposals underwent an initial technical, clinical, commercial, and regulatory review before receiving funding and in-kind service support. We noted in last years post that in Fiscal Years 2018 2022 , fewer than 100 510(k)s went through the Third Party Review Program annually. Fiscal Year 2023 showed similar performance.

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Consulting Manufacturing Utilities Provider 52

FDA Law Blog

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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Medical Electronics Manufacturing Utilities 64

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today.

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Medical Manufacturing Healthcare Government 75

FDA Law Blog

JUNE 29, 2022

It explains that “FDA typically gives greater weight to trials that are conducted in larger populations, use a well-understood and widely accepted, well-constructed clinical endpoint, and incorporate certain design features (e.g., Both documents describe the process in two steps: the intent to rescind step and the rescinding step.

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IT Clinic Provider Medical 52

FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

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IT Medical Patient-Centered Provider 69

FDA Law Blog

AUGUST 29, 2021

This policy, announced by then Associate Attorney General Rachel Brand in 2018 was referred to as the Brand Memo. clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally.

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Government Electronics IT Clinic 52

FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

NOVEMBER 20, 2024

Exhaustive extraction in these solvents can lead to high levels of product degradation or increased levels of extractables found in the chemical data, which is not expected during clinical use, and can often result in a TRA with a negative or inconclusive outcome.

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Provider Medical Manufacturing Consulting 59

FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning.

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Provider IT Engineering Medical 75

CDOCS

MARCH 31, 2021

Take clinical photos (7)<br /> 4. Send materials to the lab with clinical photos.</span></p> National Director, Clinical Technology Solutions of MicroDental Laboratories. ¹ In total, these 3 appointments could take up to 4 weeks to complete.</span></span></p>

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Appointment Families Family Patients 52

PEMBlog

SEPTEMBER 24, 2024

Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2018 Jul;48(3):247-250. Epub 2018 Apr 6. The CT also showed normal pulmonary venous return via the left lower pulmonary vein. Singh J, Dalal P, Rattan KN. doi: 10.1177/0049475518765305. PMID: 29621946. Lyon SM, Rossman MD.

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Diagnosis Diagnose Patients Asthma 52

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.

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Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). befitted a very important pathway to market for novel medical devices. The rule became final on October 5, 2021 via publication in the Federal Register. The new rule will be codified in 21 C.F.R.

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Manufacturing Government Specialization IT 52

The Clinical Problem Solvers

AUGUST 25, 2020

Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R. Trainees may use this foundation to question how this might impact their medical education and think about this educational legacy may be reformed through curricular and structural changes at their institutions. N Engl J Med 2020; 383:197-199. doi: 10.1016/S0140-6736(18)31130-9.

Community 52

Community Patient-Centered Relationship Education 52

GeriPal

JUNE 8, 2023

Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. If in your own work, your clinical work, is this something that you see people struggle with you, you see yourself struggle with? Goldilocks zone). Listen in to learn more! Nadine: I do.

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Diabetes Management Patient-Centered Families 74

FDA Law Blog

OCTOBER 5, 2022

eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. add-to-files). add-to-files). eSTAR submissions are automated (e.g.,

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Electronics Medical Screening IT 45

FDA Law Blog

MAY 25, 2022

However, even with a low PPV, a test can provide clinically useful information to providers and patients. FDA ultimately walked back its threats of enforcement action against labs offering these tests, admitting that pharmacogenomic information could be clinically useful to physicians and patients.

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