FDA Law Blog

NOVEMBER 11, 2024

As dictated by the process provided for in the 2020 CARES Act, FDA announced issuance of the proposed order in a Federal Register notice and published the proposed order itself on FDA’s website. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.

Provider 111

Provider IT Management 111

FDA Law Blog

FEBRUARY 4, 2024

The joint press release provides support for the adage that “opposites attract”; FDA claims broad authority to regulate LDTs notwithstanding its lack of statutory authority under the Federal Food, Drug, and Cosmetic Act, while CMS disavows the clear authority over clinical laboratory testing with which it has long been imbued under CLIA.

Clinic 59

Clinic Management Medical IT 59

FDA Law Blog

DECEMBER 12, 2022

In an appendix, FDA provides a model “decision check list” for patients. You should place your initials in the location provided next to each item to indicate that you have read and understood the item. This document is intended only to provide clarity to the public regarding existing requirements under the law.”

Manufacturing 52

Manufacturing Provider Patients IT 52

FDA Law Blog

NOVEMBER 1, 2023

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JUNE 21, 2022

Though the Agency’s memorandum provides little interpretive justification for this new approach, it appears to be based entirely on a superficial change in administrative practice. Until this internal memorandum was finalized, FDA’s traditional response to OTC conversion was to “remove[] the prescription listing and product number (e.g.,

IT 52

IT Provider 52

Annals of Family Medicine

NOVEMBER 20, 2024

A US-based study conducted by the Kaiser Family Foundation found 69% of patients reported avoiding discussions about death, but 92% reported feeling somewhat comfortable talking to a heath care provider about EOL wishes. Unfortunately, EOL discussions may not always include conversations around preferred place of death.

Patients 130

Patients Patient-Centered Provider Education 130

CDOCS

MARCH 15, 2021

Our goal is to provide the same engaging, informative, and educational content, only in a digital manner. important;" xml:lang="EN-US">We started our small, little company way back in the day in 2006. important;" xml:lang="EN-US">So, with this, we kick off the new CDOCS Digital Magazine.

Families 52

Families Family Education Community 52

Permanente Medicine

JUNE 3, 2025

I joined SCPMG straight from residency in 2006. Can we talk more about the evolving landscape within which we all have to operate as Kaiser Permanente, but also as physicians and health care providers and how patients’ perceptions and the experience they have can impact those choices and the business of medicine?

IT 52

IT Patient-Centered Patients Medical 52

FDA Law Blog

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient.

Healthcare 59

Healthcare Diagnosis Provider Individual 59

GeriPal

MARCH 2, 2023

2006 Transcript Eric: Welcome to the GeriPal Podcast. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? But also just in my limited practice, and I’m a relatively new provider, I’ve just noticed that pain management is so individualized.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law Blog

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S. The penalty provisions provide, in relevant part: (e) Penalties.— (1) 1) FORFEITURE.—Each

Manufacturing 59

Manufacturing Provider IT 59

GeriPal

JUNE 22, 2023

Through a series of events, I started working as a consultant to the Department of Corrections in around 2006, and I was assigned to the California Medical Facility. And that grew into a group of volunteers coming back and at least providing support groups, giving those men a place where they could talk at least. Michele: Yep.

Family 132

Family Families IT Community 132

FDA Law Blog

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. 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful.

IT 80

IT Provider Consulting 80

GeriPal

JULY 6, 2023

Started as a direct case manager, worked in a variety of different places including the state legislature and I’ve been with the state office now since 2006. It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. Eric: And Susan?

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

MAY 1, 2025

Have been now a care provider for people with HIV for over 40 years. And I became more and more involved in it, including becoming involved in research and developing some of the programs initially to provide care for people with both drug use and HIV related problems, women with HIV vulnerable populations. I don’t know exactly.

Primary Care 94

Primary Care IT Clinic Provider 94

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Eric: Okay.

Patient-Centered 125

Patient-Centered IT Family Families 125

FDA Law Blog

JUNE 9, 2021

As explained in CPG 440.100 and on FDA’s website , FDA adopted the “Unapproved Drug Initiative” (“UDI”) in 2006—later revised in 2011 —to remove unapproved drugs from the market using a risk-based approach both to ensure the safety and efficacy of all drug products on the market and the integrity of the drug approval process.

IT 52

IT Consulting Manufacturing Provider 52