ABIM

MAY 18, 2025

Diagnostic delays, racial and ethnic health disparities, insurance barriers, and restricted access to appropriate treatments compound the emotional and physical burden of living with IBD. Without a full understanding of the disease context, he recommended surgery that, in hindsight, was not the medically appropriate next step.

Diagnose 40

Diagnose Healthcare Diagnosis Physicals 40

FDA Law

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. CDRH recently announced its acceptance and hosting of in-person meetings, including hybrid options that allow for both physical and virtual participation.

Screening 59

Screening Transportation Provider Electronics 59

FDA Law

JANUARY 12, 2025

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

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. It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law

MARCH 24, 2024

The federal government has long maintained that state law offers an additional, and important, layer of consumer protection that complements federal regulation. Impossibility preemption exists when it is physically impossible for a private party to comply with both state and federal law.

Manufacturing 59

Manufacturing Government IT Provider 59

FDA Law

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Firms also need to maintain distribution records to facilitate identifying the direct accounts that received the recalled product by name, physical address where the product was delivered, and contact information. By Philip Won & Lisa M.

Electronics 40

Electronics Manufacturing Provider IT 40