FDA Law

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. Notably, FDAs public WL database only goes back to 2020.

Manufacturing 64

Manufacturing Provider Consulting IT 64

FDA Law

AUGUST 21, 2023

We note that in December 2020, the same U.S. 2, 2020 ( DOJ Press Release ). Regulated sellers must train employees on SCLP sales requirement content developed by DEA and listed on the DEA website provided at the Diversion Control Division Retail Training Page. 21 U.S.C. § 830(e)(1)(B)(i).

Consulting 52

Consulting Provider IT 52

FDA Law

NOVEMBER 7, 2024

If a company and/or their regulatory consultant(s)/counsel have evaluated the product and determined it is not a device, the company can decide to proceed to market the product without contacting FDA. Sometimes, though, the question of classification defies an easy answer.

Provider 69

Provider IT Consulting Utilities 69

FDA Law

AUGUST 23, 2021

These revisions appear to be responsive to a November 16, 2020 Special Fraud Alert issued by the Office of Inspector General at the U.S. The new Code continues to permit incidental meals that are modest by local standards (still without defining “modest”), but adds a prohibition on providing alcohol.

Specialization 52

Specialization Manufacturing Education Provider 52

FDA Law

FEBRUARY 1, 2022

And we were even more excited when that release was followed closely by an FDA Report on the comments submitted to FDA in 2020 and 2021 on the listing of patent information in the Orange Book. In response to these comments, FDA convened a working group but declined to provide recommendations to Congress that would help address these issues.

Provider 52

Provider IT Consulting Manufacturing 52

PEMBlog

OCTOBER 18, 2024

Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2020 Jun 5;15(1):141. DMD patients often receive yearly MRIs to monitor their cardiac health, as discrepancies between MRI and echo findings are common. Orphanet J Rare Dis.

Patients 52

Patients Complication Management Consulting 52

GeriPal

JANUARY 12, 2023

Number four, again, structure and process that promotes early mobilization which may or may not require a formal OT and PT consultation. Yes, you need some protected time for leaders to provide training and structure and oversight and ongoing quality assurance, but the heaviest sort of cost lift sometimes is redesigning the physical space.

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

PEMBlog

SEPTEMBER 13, 2023

A careful history and physical examination are ways that we as providers can “see what’s going on inside the head.” Reaffirmed October 17, 2020 Riviello JJ Jr, Ashwal S, Hirtz D, et al; American Academy of Neurology Subcommittee; Practice Committee of the Child Neurology Society. 2000; 55(5):616-623.

Patients 52

Patients Screening Illness Physicals 52

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. So learning more about how to inform providers on how to make decisions about de-prescribing based on prognosis, based on diabetes type, based on their oral intake and their goals.

Diabetes 73

Diabetes Management Patient-Centered Family 73

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. “We step into places where other providers may not, and geriatrics is a prime example of that.” “Hello. How are you feeling?”

Nurse Practitioner 52

Nurse Practitioner Family Families Primary Care 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. They can use their training and privilege to advocate for meaningful policy reform.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JANUARY 30, 2025

In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. Consultations versus telehealth. But watch out! That’s what I’m waiting for, Alex.

Telehealth 105

Telehealth Patient-Centered IT Patients 105

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. With their regular providers? The article we discuss today, also published in JAMA , addresses these two gaps. In their communities?

Patient-Centered 122

Patient-Centered IT Illness Patients 122

ABIM

JUNE 4, 2025

A workgroup convened in 2020 found that the existing practice categories candidates could choose were inadequate to the real scope of community practice and proposed updates drawn from the American Medical Association and the Diplomate Professional Profile.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

GeriPal

OCTOBER 26, 2023

And so I did all of my research training in health services research, health policy, and then was very grateful to be recruited by Dr. Christine Ritchie when she transitioned here to MGH in September of 2020. Tamra: I wrote this… Eric: Thinking that the perceived role for inpatient physical therapist is a discharge consultant.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

DECEMBER 8, 2022

So those questions we ask when we’re doing a palliative care consult. And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers? Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Bennett, C.R., Schilling, L.,

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

GeriPal

FEBRUARY 13, 2025

You did a rural tele-palliative care consultation study. And so the video consult was what became the mode. Marie 03:42 So probably the most important thing is we developed the consultation as a culturally based consultation process. And then we incorporated that information into the consultation process.

Consulting 63

Consulting Community Patient-Centered Family 63

GeriPal

JANUARY 20, 2023

You were on a National Academy of Sciences committee started in 2020? To me, I think the Greenhouse folks have proven that you can provide quality care in a home-like environment cost effectively if it’s done right. Eric: All right, let’s jump into this topic. Improving nursing home quality. Jasmine: Yes. Is that right?

Finance 95

Finance Board-Certified IT Provider 95

FDA Law

JULY 9, 2024

For rare diseases, although patient numbers may be too small to detect meaningful differences in safety or effectiveness, the Draft Guidance states that consistent representative enrollment may still provide opportunities for hypothesis generation and further study. providing language assistance); Reducing participant burden (e.g.,

Clinic 59

Clinic Provider Individual IT 59

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. I think that study was really important, especially I think the message that I give people is you can do something as simple as calling a consultation and improve quality of life months later.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

FDA Law

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs. FDA, for years, has been concerned with overwarning.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law

DECEMBER 3, 2024

142 includes some new provisions (compared to previous iterations of the bill) to expressly provide for the Federal trade Commission (“FTC”) to obtain forfeiture and civil penalties in an administrative proceeding initiated by the Commission. The FTC in a 2020 report. As we noted in our prior post, S. 44 et seq. )

IT 80

IT Provider Consulting 80

BMJ

AUGUST 20, 2021

In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions. Over one billion prescriptions per year are signed in the UK by these general practitioners (GPs) in primary care.

Primary Care 40

Primary Care Supply Chain General Practitioner Vaccination 40

GeriPal

NOVEMBER 3, 2022

So take a listen and check out some of these resources for healthcare provider loss, grief, and wellness: Loss and Grief: Personal Stories of Doctors and Other Healthcare Professionals. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Craig: Thanks so much, Alex and Eric.

Healthcare Professional 102

Healthcare Professional Healthcare IT Relationship 102

FDA Law

JUNE 9, 2021

Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.

IT 52

IT Consulting Manufacturing Provider 52