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. Not just because of the physical toll, but because I endured them in silence. comes with serious challenges, ones that often go unseen by the public.
FDA Law Blog
OCTOBER 26, 2022
In the interim, the issue has reared its head again in FDA’s recently issued guidance for industry, titled Refusal of Inspection by a Foreign Food Establishment or Foreign Government. . That refusal is executed administratively, with no need to involve lawyers or judges, and the results can be highly disruptive. See here and here.
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FDA Law Blog
APRIL 19, 2021
We have blogged recently about several FDA setbacks in court ( here , for example). As most readers of our blog are aware, the regulatory costs to manufacturers of medical products are much lower if FDA regulates a product as a medical device rather than a drug requiring FDA marketing approval. By Douglas B. Farquhar & Sara W.
FDA Law Blog
SEPTEMBER 17, 2023
CDRH recently announced its acceptance and hosting of in-person meetings, including hybrid options that allow for both physical and virtual participation. Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in.
FDA Law Blog
JANUARY 12, 2025
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. For those somewhat familiar with accelerated approval and surrogate endpoints, you will find that the guidance reiterates a now well-established framework.
FDA Law Blog
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. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36 Million to Settle Claims of Controlled Substance Act Violations (June 8, 2022).
FDA Law Blog
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.
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