FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision. By Steven J.

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IT Manufacturing Government Clinic 64

FDA Law

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. The regulatory requirements for the devices that are 3D-printed generally govern the responsibilities of the entities that are manufacturing and distributing the 3D printing equipment for that use at the point of care.

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Hyman, Phelps & McNamara, P.C. (HP&M),

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Government Provider Medical 59

FDA Law

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That’s a good list of the kinds of things that most consumers really do not want their digital medical services provider to do with their sensitive personal information.

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Patient-Centered Telehealth IT Government 105

FDA Law

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. The discount code is: S10-826-826L24.S.

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Private Practice Specialization Government Management 52

FDA Law

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. The regulatory requirements for the devices that are 3D-printed generally govern the responsibilities of the entities that are manufacturing and distributing the 3D printing equipment for that use at the point of care.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

FEBRUARY 26, 2025

With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance word. The answer to that is still no, the current state of world and governmental events notwithstanding. HPM Counsel John W.M.

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Supply Chain Management Manufacturing IT 66

FDA Law

AUGUST 23, 2021

The PhRMA Code is updated periodically to reflect changes in industry norms or, as is likely the case with the latest revision, in response to political pressure or increased scrutiny from the federal government. If held in a third-party venue, the venue “should not be extravagant or the main attraction of the event” (e.g.,

Specialization 52

Specialization Manufacturing Education Provider 52

Permanente Medicine

MAY 20, 2025

” “Whether you’re the call center agent, the receptionist, [or] the lab tech, you participate and you provide the input into innovation,” said Dr. Nguyen. The Southern California Permanente Medical Group is one of the largest medical groups in the nation with more than 8,800 physicians providing care for over 4.8

Patient-Centered 52

Patient-Centered Patients Medical IT 52

FDA Law

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA.

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Government Clinic Individual Provider 40

FDA Law

MARCH 16, 2022

In a later session, she will join a panel of experts to answer questions about developments in drug pricing transparency requirements and provide practical advice to implementing the state requirements. You can access conference information and register for the event here. The discount code is 22HYMAN10.

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Provider Government 40

FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

JUNE 12, 2023

PFI’s frustration and concern around the current regulatory process overseen by state governments was discussed during the Petfood Forum 2023 convention in Kansas City, MO. AFIA highlighted the impact the new framework could have for ingredient suppliers that provide products for all animals, including livestock, dogs, and cats.

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Manufacturing Individual Government Illness 45

FDA Law

JULY 24, 2023

Its main argument is that Congress included only two exceptions to FDA’s restriction barring FDA from granting new approvals during the ODE period: the inability to provide sufficient quantities of a drug and consent from the ODE holder.

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Clinic Provider IT Patients 52

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. And this is really traumatic event for his street family and the street community that he knew. They can’t believe it, but we come back again and again and again gently to provide that support.

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Healthcare IT Community Illness 100

GeriPal

OCTOBER 20, 2022

This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. We talk about: . difficile infections.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

JUNE 26, 2025

Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Today we talk about disruptive events, or health and wealth shocks. And the government can do something about that?!? Alex 03:41 Okay, so today we’re going to talk about disruptive events.

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Illness Hospital IT Patient-Centered 93

GeriPal

SEPTEMBER 5, 2024

So in some ways, it was an iatrogenic event. There was also a second event in that the pressures chosen weren’t the ideal ones. I mean, obviously nobody fed her the pill with the intention of choking her, but it wasn’t like suddenly she had another event out of the blue because she had a bad heart.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

JULY 6, 2023

It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. The long-term care is being actually provided in the community at a much higher rate than what the formal system provides. But, what you need is a community-based game there.

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Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. What do we do to very concretely provide heat shelters and cool shelters?

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Healthcare IT Education Community 129

GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. Talent is something, but it’s really about putting in the work and then keeping also to place it somewhere or waiting for an event. Rosanne: I certainly do.

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IT Healthcare Professional Healthcare Transportation 105

FDA Law

JANUARY 24, 2024

Section 1 of the Executive Order laid out the Biden Administration’s policy to, among other things, “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”

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Supply Chain Manufacturing Government Provider 69

GeriPal

APRIL 20, 2023

Sometime after the age of 50, we could identify an event where the folks who were first homeless before 50, there wasn’t a clear crisis that precipitated it. Folks who were first homeless after 50, there was an event, and usually those events could be described in one of four categories. But they were poor, really poor.

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Mental Health IT Community Individual 123

Physician's Weekly

JUNE 12, 2025

An “improper” payment refers to payments made erroneously to beneficiaries and their providers or without sufficient documentation. Other experts told PolitiFact that the actual numbers could be higher than what the federal government reports, although not as high as Paragon’s estimate.

Government 52

Government Provider Insurance IT 52

FDA Law

APRIL 21, 2021

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. 393(d)) provides that the Secretary ‘shall be responsible for executing’ the FD&C Act ‘through the [FDA] Commissioner.’

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Manufacturing Government IT Consulting 40

FDA Law

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. The LDT Rule itself provides no operational guidance, but only a definition. Perhaps most notable in yesterdays argument, though, was what didnt happen.

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Patient-Centered Consulting Government Clinic 102

Physician's Weekly

JUNE 26, 2025

A Failed Compensation Program Vaccine advocates and skeptics agree that the government program established to compensate people injured by vaccines or other public health measures during emergencies — the Countermeasures Injury Compensation Program — has miserably failed those with covid vaccine-related injuries.

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Vaccination Patient-Centered Government IT 52

Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. In the 1980s, the government refused to acknowledge HIV as gay men died young.

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Government Community Family Families 52

FDA Law

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. The government would require at least another 30 days to examine the shipment at the U.S.

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Supply Chain Manufacturing Chronic Condition Government 59