FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

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FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee.

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FDA Law Blog

JULY 19, 2022

On the other hand, labels that bear so-called “special statements and claims” must be submitted to and approved by FSIS’s Labeling Program and Delivery Staff before they can be used on meat or poultry products. The list of special statements and claims, in FSIS regulation 9 CFR 412.1 (e), e), includes so called “animal raising claims.”

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FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. 510(k) Time to MDUFA IV Decision.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology [published correction appears in J Am Coll Cardiol. 2019 Jun 25;73(24):3234]. J Am Coll Cardiol. 2019;73(24):3153-3167.

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FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

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FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). By Asking Them.

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Patients Patient-Centered Clinic IT 52

Annals of Family Medicine

NOVEMBER 20, 2024

This specialized workforce has not yet been classified in health administrative data, limiting our understanding of their individual and medical practice characteristics. Study design and setting: Retrospective cohort study using multiple population-based health administrative datasets in Ontario, Canada in 2019.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. They can use their training and privilege to advocate for meaningful policy reform.

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Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

APRIL 5, 2022

During this episode, we gained insight from special guests Dr. Margot Kushel and Mr. Bobby Watts about what brought them into their fields, how their work reaches the most marginalized, and what can be done at the community and structural level to address homelessness. Published April 5, 2019. January 18, 2019. Rothstein, R.

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FDA Law Blog

JUNE 10, 2024

The hospital also “entered into a Memorandum of Agreement with the DEA requiring Palomar Health to undertake additional measures to increase security, implement specialized training, and to handle controlled substances properly and safely.” Palomar Health self-disclosed to DEA that one of its employees may have diverted the fentanyl.

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Physician's Weekly

JUNE 19, 2025

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. Like I’m having to go outside of that in order to get them the medications that are nothing special. As always, DEFINITELY please let us know how the stuff we provide can be even better. Dan: Yeah, fair.

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Insurance IT Board-Certified Medical 52

GeriPal

MARCH 24, 2023

She happened to focus on some specific for-profit hospice providers. They were all actually publicly traded or private equity owned for-profit hospice providers. And I didn’t read it as damning of all for-profit providers, but I think it needed to happen. It feels somewhat random in some ways. Eric: Lack of a caregiver.

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GeriPal

AUGUST 25, 2022

Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. -@AlexSmithMD. Transcript.

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Family Families IT Patients 106

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. James 01:34 Yeah, right on.

Illness 107

Illness IT Patient-Centered Patients 107

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate.

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FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

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Specialization Manufacturing Electronics PCP 69

GeriPal

APRIL 26, 2024

Some numbers to back it up: ELNEC has trained more than 48,000 providers in a train the trainer model Over 1.5 We started writing this paper in 2019 actually. Eric: So not from the patient perspective or family, but from the provider perspective? And then we have providers. AMA PRA Category 1 credit(s) ™. Bry: Yeah, Eric.

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Patient-Centered IT Patients Consulting 119

Physician's Weekly

JUNE 12, 2025

An “improper” payment refers to payments made erroneously to beneficiaries and their providers or without sufficient documentation. From 2017 to 2019, during Trump’s first term, Blase served as Trump’s special assistant for economic policy. The White House did not respond to an inquiry for this article.

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Government Provider Insurance IT 52

FDA Law Blog

MAY 13, 2025

Given that the provision in the May 12 EO may be a rehash of what occurred in 2020, we thought it would be helpful to provide a bit of history and background on personal importations. Instead, FDAs webpage on Personal Importation provides that [i]f a drug is approved for use in another country but is an unapproved new drug in the U.S.

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Manufacturing IT Individual Provider 59