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FDLI’s Annual Gathering of FDA Lawyers Yields Insights into Agency Priorities

By Jennifer Tharp, Delia Deschaine, Kara-Marie Urban, John Wyand and Nicole Bothwell on Posted in Events, FDA, Life Sciences, Medical Device
This May, the food and drug law community gathered at an annual conference hosted by the Food and Drug Law Institute (“FDLI”) in Washington DC. The agenda featured speakers across the agency, including former Commissioner Makary, current Acting FDA Commissioner Kyle Diamantas, Grace Graham, Sara Brenner, FDA Chief Counsel Sean R. Keveney and leaders from … Continue Reading

U.S. Government Shutdown 2025 (Week 1):  Early Insights into FDA Operations

By Delia Deschaine, John Wyand and Xiaomei Cai on Posted in Events, FDA
The 2025 U.S. government shutdown kicked in effective at 12:01am, October 1, 2025, and as of this posting, has been in place for over a week.  The shutdown will continue indefinitely until Congress unifies and resolves the budget impasse. The U.S. Food and Drug Administration (“FDA”), tasked with protecting public health by ensuring the safety, … Continue Reading

Data Security: Pay IT Now or Pay Out Later

By Squire Patton Boggs on Posted in Compliance, Department of Health and Human Services, Electronic Health Records, Events, Technology
The price of compliance may be high, but the price of non-compliance is even higher. Based on its recent $3 million data breach settlement, AvMed, and many other entities that have experienced data breach litigation, would likely agree that paying for security upgrades now, is far superior to paying for data breaches later. In 2009, … Continue Reading

ACO Webinar Reminder: Today at 2:00 P.M. (EDT)

By Squire Patton Boggs on Posted in Accountable Care Organizations, Events
Today at 2:00 P.M. (EDT), please join Squire Sanders and Strategic Health Care for our complimentary webinar overview of the final rule recently released by the Centers for Medicare & Medicaid Services (CMS) and the opportunities it presents for Accountable Care Organizations (ACOs). Speakers will include our own John Kirsner and Peter Pavarini as well as … Continue Reading

Webinar: Implications of the New ACO Regulations Announced for November 3

By Squire Patton Boggs on Posted in Accountable Care Organizations, Events
On Thursday, November 3rd, please join Squire, Sanders & Dempsey and Strategic Health Care for a complimentary webinar overview of the final rule recently released by the Centers for Medicare & Medicaid Services (CMS) and the opportunities it presents for Accountable Care Organizations (ACOs). As reported by the Accountable Care Forum, CMS made significant changes in … Continue Reading

ACO Regulation Review and Application Preparation Webinar

By Squire Patton Boggs on Posted in Accountable Care Organizations, Events
Join Squire Sanders and Strategic Health Care this Friday, April 8 at 11 a.m. EDT for a national webinar, “ACO Regulation Review and Application Preparation.” Squire Sanders partners Peter A. Pavarini and John M. Kirsner will discuss legal considerations relevant to the proposed Accountable Care Organization (ACO) regulations issued by the Centers for Medicare & Medicaid Services … Continue Reading
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