FDA Law

OCTOBER 3, 2022

For example, the government closely scrutinizes speaker programs or trainings that involve lavish venues or meals and free alcohol, invite attendees with no legitimate business reason to attend, and present little substantive information to them. The Alert described several factors that could potentially violate the antikickback statute.

Consulting 105

Consulting Healthcare Professional Specialization Government 105

FDA Law

MARCH 7, 2024

What started as a day has — due to its popularity and the persistent efforts of patients and industry — evolved into a week-long event. And my support and pride continue since we now see a host of programs and events the last week of February playing out around the world.

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Government Community Specialization Education 69

FDA Law

MAY 15, 2025

You can access conference information and register for the event here. FDA Law Blog readers are offered a discount of 10% off the registration price. The discount code is 25HYMAN10.

Government 59

Government Provider 59

FDA Law

AUGUST 26, 2021

To hold a corporation liable for these actions, the government must establish that the corporate agent’s actions (i) were within the scope of his duties and (ii) were intended, at least in part, to benefit the corporation. In light of the above, the government generally resists the notion that an organization is a victim of its own employees.

Government 98

Government Manufacturing Individual IT 98

FDA Law

JULY 22, 2024

Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” s John W.M. s John W.M. You can register for the conference here. FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ).

Government 59

Government IT 59

FDA Law

FEBRUARY 26, 2024

The event is set to take place from March 4-6, 2024, in San Francisco, California. Walsh has garnered acclaim for her passionate efforts in assisting companies with preventing or responding to government investigations, conducting internal investigations to ensure compliance, and defending against DOJ prosecutions. More notably, Ms.

Government 59

Government IT Medical 59

FDA Law

APRIL 7, 2025

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

Specialization 59

Specialization Government 59

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.

IT 64

IT Manufacturing Government Clinic 64

ABIM

APRIL 24, 2025

Community Practice in ABIM Governance* Dr. Johnson led a discussion with the Rheumatology Board on community practice in rheumatology to create a more inclusive understanding of its role and scope. Get Involved Apply to openings on ABIM Governance and the Item-Writing Task Forces and be part of shaping the future of ABIM’s assessments.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

JULY 30, 2024

Several leading ladies in law at HPM attended the conference and, based on their feedback, gave the annual event an A+ rating. Women in Government and Judiciary Roundtable. Highlights: CEO Spotlight Interviews.

Government 52

Government Medical IT 52

FDA Law

JANUARY 18, 2022

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. complaint handling and adverse event reporting processes) and staff trained in the maintenance of equipment.

Medical 98

Medical Manufacturing Healthcare Government 98

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.

Private Practice 52

Private Practice Specialization Government Management 52

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 kind of event probably triggers the Health Breach Notification Rule, and a civil action against the victim company for poor data privacy practices may not be far behind.

Patient-Centered 105

Patient-Centered Telehealth IT Government 105

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), Before joining HP&M, Ms.

Government 59

Government Provider Medical 59

Evergreen Family Medicine

FEBRUARY 1, 2024

Still, as a physician in my 44th year of practice, the events of the past several years have had a profound effect on the way I think of the care I have been rendering.The CDC and NIH manipulated the government and the willing press into supporting incredibly corrupt behavior.

Government 40

Government Medical IT 40

FDA Law

JANUARY 5, 2023

But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health. Until that happens, interested parties in this space continue to face many of the same cybersecurity threats as other data-tech entities.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

PEMBlog

MAY 31, 2023

Government. Qualitative study of patient experiences and care observations during agitation events in the emergency department: implications for systems-based practice. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

Management 89

Management Patient-Centered Finance Transportation 89

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.

Supply Chain 66

Supply Chain Management IT Manufacturing 66

Family Physicians of St. Joseph

MARCH 14, 2018

From the Detroit News If there’s any more argument to be made about getting third-party insurers — whether government or private insurance — out of most routine health care, here’s one. That is, Savage does not work with third-party payers — government or private insurance, period. And it’s a true story.

Insurance 52

Insurance Medical Primary Care Government 52

FDA Law

JANUARY 18, 2022

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. complaint handling and adverse event reporting processes) and staff trained in the maintenance of equipment.

Medical 75

Medical Manufacturing Healthcare Government 75

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

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.

Government 40

Government Clinic Individual Provider 40

FDA Law

MARCH 16, 2022

This hybrid event brings together experts working in or with the pharmaceutical and biotechnology industries to share best practices and discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices. The discount code is 22HYMAN10.

Provider 40

Provider Government 40

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. PFI has noted that it is not feasible to develop and label products for an individual state.

Manufacturing 45

Manufacturing Individual Government Illness 45

FDA Law

JULY 24, 2023

More specific to the facts of this case than the governing statute, Jazz argues that OOPD’s determination that Lumryz is clinically superior to Xywav is inconsistent with FDA’s regulations.

Clinic 52

Clinic Provider IT Patients 52

FDA Law

JANUARY 12, 2025

FDAs Overview of When Accelerated Approval is Appropriate The new draft guidance explains, that there are two circumstances in which the accelerated approval authority would most clearly apply: (1) when the course of the disease is long or (2) the clinical event that is relevant for demonstrating benefit occurs infrequently.

Clinic 64

Clinic Relationship Provider IT 64

Permanente Medicine

MAY 20, 2025

I know for a fact that the government or legislators looked to us in Permanente. Also understanding where pharmacies would not be available because of the catastrophes that were going on. So putting that all together to prevent disasters is at the heart of what we’re trying to do. And then putting that on steroids with AI.

Patient-Centered 52

Patient-Centered Patients Medical IT 52

FDA Law

DECEMBER 21, 2023

Additionally, there will be smaller touches that often go overlooked like podium branding, event signage, publication cover art and more. But FDLI is also thinking beyond logos and websites—2024 will be filled with events to mark FDLI’s 75th anniversary.

Finance 59

Finance Government Medical IT 59

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

FDA Law

JUNE 12, 2022

The DOJ contends that a failure to report adverse events as required under FDA’s regulations could mask problems that would have led FDA “to institute or require a product recall.”. There are other objections to the DOJ’s proposed use of adverse event reporting to support a fraud?on?the?FDA FDA theory.

IT 52

IT Manufacturing Government 52

FDA Law

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation.

Clinic 59

Clinic IT Healthcare Medical 59

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.

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

OCTOBER 20, 2022

For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. We talk about: . The structure of federal agencies and how they coordinate. Priorities of the National Alzheimer’s Project Act, and the unique role of ASPE and BHDAP in guiding the agenda and long-term goals.

Complication 52

Complication Patient-Centered IT Patients 52

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

MARCH 6, 2025

And this is really traumatic event for his street family and the street community that he knew. Government is not the 51st state. And I remember getting to the shelter the next day after meeting him early and not finding him anywhere and learning later that he had died overnight.

Healthcare 100

Healthcare IT Community Illness 100

GeriPal

MARCH 16, 2023

Like in pandemic, I wrote a few articles early on and then when I started working for the city and state, I just stopped and partly was the horrible, horrible, horrible things we were seeing and that the government was doing to older people. And part of it was just not having time because I was doing my UCSF job and that job.

IT 105

IT Healthcare Professional Healthcare Transportation 105

Physician's Weekly

JUNE 12, 2025

In a 2005 article for Rolling Stone that was later retracted, Kennedy claimed government officials had buried data showing a link between vaccines and autism, The Wall Street Journal said. Children’s Health Defense, an anti-vaccine nonprofit Kennedy once led, is holding an online event this week to mark what it calls the “autism cover-up.”

Vaccination 52

Vaccination Patient-Centered Government Diagnosis 52