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ABIM
MAY 18, 2025
This burden of the disease is being felt by patients and healthcare providers. 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. During that time, I endured two debilitating surgeries.
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
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. Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. Be ready with backup options (e.g.,
FDA Law Blog
JANUARY 12, 2025
Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. 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.
FDA Law Blog
APRIL 19, 2021
We have blogged recently about several FDA setbacks in court ( here , for example). The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug.
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. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.
FDA Law Blog
MARCH 24, 2024
The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested 340B drugs to be delivered to, and dispensed from, a network of contract pharmacies. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.
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