FDA Law Blog

DECEMBER 16, 2024

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review. Fiscal Year 2023 showed similar performance.

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The Clinical Problem Solvers

APRIL 24, 2025

Additionally, he consults with federal agencies on mental health system design and practices. Dr.  2020 Nov 12;383(20):1904-1905. 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. JAMA Netw Open.

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FDA Law Blog

APRIL 22, 2024

The UN Commission on Narcotic Drugs removed cannabis and cannabis resin from schedule IV of the Single Convention in December 2020. Whether DEA is consulting the Department of State about treaty obligations regarding marijuana and diplomatic implications of rescheduling? Whether DEA believes the U.S.

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Today's Hospitalist

MAY 9, 2025

Looking ahead, here are several emerging innovations that promise to shape the next generation of these tools: Deeper integration with hospitalist workflow: Initiating an AI-assisted note may soon be as effortless as speaking naturally during a patient consult—no disruptions, no clicks. References: 1. Shanafelt TD, West CP, Sinsky C, et al.

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FDA Law Blog

AUGUST 21, 2023

We note that in December 2020, the same U.S. 2, 2020 ( DOJ Press Release ). In the unlikely event a regulated seller cannot recall whether they have self-certified, they can consult DEA’s monthly self-certification list of all who have current self-certifications found at the Diversion Control Division CMEA Monthly List.

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FDA Law Blog

FEBRUARY 23, 2025

Notably, FDAs public WL database only goes back to 2020. 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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FDA Law Blog

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. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

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FDA Law Blog

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 current Code discourages the use of resort venues for several types of meetings, including consultant meetings, speaker programs, and speaker training meetings.

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PEMBlog

OCTOBER 18, 2024

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. 2020 Jun 5;15(1):141. References Crisafulli S, Sultana J, Fontana A, Salvo F, Messina S, Trifirò G. Orphanet J Rare Dis.

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FDA Law Blog

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.

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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. So their Stephanie is now launching their consult service and perhaps eventually their ACE unit, who will then reach into their affiliate. That hospital has several affiliate hospitals.

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PEMBlog

SEPTEMBER 13, 2023

If the patient has a history of high-risk conditions (like sickle cell anemia, coagulopathies, neoplasm, or age <6 months), those patients might be at higher risk of comorbidities, and further testing or consultations with the appropriate specialist might be appropriate. 2000; 55(5):616-623.

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GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. From Beth Israel and UNC. Beth, welcome to GeriPal.

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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. There’s this great article and I’ll send it to you all, it’s called End-of-Life Care Requires Caution With Use of Continuous Glucose Monitoring, JPM, from 2020.

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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. ” A month after the consult, Ellen died peacefully in her sleep. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit.

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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. You get a consult if you get a consult.

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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. Epub 2020 Dec 3. Academic Psychiatry , 45 (1), 78–83. link] Castillo, E. DeBonis, K. Braslow, J. 2020.108218.

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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.

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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. So, the docs actually wrote orders for tests, medications, consults. And Lyndsay can share some of that, if you’re interested.

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PEMBlog

OCTOBER 19, 2023

Additional labs ordered per the consultant’s recommendations were notable for elevated PT/PTT, AFP, plasma tyrosine, and urine succinylacetone consistent with a diagnosis of tyrosinemia. 2020 Jun 5;38:e2018158. doi: 10.1590/1984-0462/2020/38/2018158. TYROSINEMIA TYPE III: A CASE REPORT OF SIBLINGS AND LITERATURE REVIEW.

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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.

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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.

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GeriPal

DECEMBER 8, 2022

So those questions we ask when we’re doing a palliative care consult. Or volunteers, we have volunteers on our palliative care team that are doing story catching, not in my research project because I don’t have persons who are receiving formal palliative care consults. Bennett, C.R., Schilling, L., Doorenbos, A.

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FDA Law Blog

AUGUST 21, 2023

The passage of the OTC monograph provisions of the 2020 CARES Act was intended to address the lack of resources, and user fees are being collected, but, as expected, implementing all the other aspects of the new law is a long process.

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GeriPal

APRIL 10, 2025

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. Remember, this was March 2020, around that time when we got all this training and we were having now these conversations really often.

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FDA Law Blog

JULY 9, 2024

FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies. providing language assistance); Reducing participant burden (e.g.,

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GeriPal

JANUARY 20, 2023

You were on a National Academy of Sciences committee started in 2020? They’ve brought on experts, they’ve brought on additional people who are researchers or consultants who do this work all day long, and have added a lot of content. Eric: All right, let’s jump into this topic. Improving nursing home quality.

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GeriPal

DECEMBER 5, 2024

That was January 2020. We had, you know, it was a Monday night in June of 2020. His lymphoma had relapsed, and palliative care was consulted to help with his symptoms. We’ve got to do that. I mean, it’s Boston in the winter, so we’re going to wait until the spring to go to someone’s backyard.

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FDA Law Blog

DECEMBER 3, 2024

The FTC in a 2020 report. That is, that the FTC may be granted the authority to run to district court without consulting the Department of Justice. “The Act as written is probably not going to fly.” Emily Michiko Morris: “What’s happened is that the FTC requires that these cases submit their settlement terms to the FTC for review.

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BMJ

AUGUST 20, 2021

We sought to analyse how prescribing trends have changed over time, utilising a dataset containing all prescriptions signed and dispensed in the UK by primary care facilities from January 2014 to November 2020. Despite the spike in prescribing of insulins, oral antidiabetic medications were not similarly affected.

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GeriPal

NOVEMBER 3, 2022

Susan Block had reached out to me and asked if I could contribute something specifically on the experience during the peak months in New York City and COVID Pandemic in 2020. And then to see her show up in our hospice unit in April of 2020, it just completely broke my heart. She was homeless.

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FDA Law Blog

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.

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