FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

Provider 59

Provider Screening IT Government 59

FDA Law Blog

JUNE 16, 2023

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is.

Manufacturing 45

Manufacturing Provider Consulting IT 45

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. Richard Rothstein References Rothstein, R.

Government 52

Government Community Education Individual 52

FDA Law Blog

NOVEMBER 18, 2021

The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). On the minus side, a rapid antigen test may miss an infected individual with a low viral load (e.g., PCR comparators for their clinical studies but refuses to publicly designate which ones are acceptable.

Screening 98

Screening Healthcare IT Manufacturing 98

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). Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” Your breast tissue is not dense.

Healthcare 59

Healthcare Diagnosis Provider Individual 59

FDA Law Blog

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law Blog

APRIL 8, 2024

What about government factors that cause drug shortages? What the White Paper does not adequately address is whether there are any government-controlled factors that also cause drug shortages. We recently summarized another GAO report which described challenges FDA continues to face with clinical research inspections.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Best Price Stacking We previously blogged about the 4 th Circuit Court of Appeals decision in United States Ex Rel. Sheldon, v.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

JANUARY 11, 2024

Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Sonu: Prior to that it was illegal and actually in the criminal code, so not only illegal, it’s actually a prohibition in the clinical code. Bill, welcome back to GeriPal.

Illness 144

Illness IT Medical Provider 144

GeriPal

MARCH 16, 2023

And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. In clinic, I’m helping what, hundreds or thousands. When I write, I learn a ton from that. And I tend to think of writing as my version of public health. Even if I write a scholarly article.

IT 105

IT Healthcare Professional Healthcare Transportation 105

FDA Law Blog

NOVEMBER 18, 2024

Kennedy’s pronouncements raise serious concerns as to whether scientific evidence and clinical data will continue to serve as the principles by which FDA makes critical decisions each and every day, or whether his beliefs – or the beliefs of new FDA officials he gets to select – will drive FDA decisions. To some degree.

Appointment 116

Appointment Vaccination Patient-Centered IT 116

FDA Law Blog

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98