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Blank Rome partner <a href="/people/thomas-m-sundlof/" id="18273">Thomas M. Sundlof</a> will serve as a presenter at American Conference Institute’s (“ACI”) <a href="https://www.americanconference.com/fda-boot-camp/">44th Annual FDA Boot Camp</a>, being held March 25 through 26, 2026, at the New York City Bar in New York, New York.

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With the Food and Drug Administration (“FDA”) rolling out artificial intelligence (“AI”)-enabled device and predetermined change control plans (“PCCP”) guidances; recalibrating its stance on laboratory developed test (“LDT”) oversight after court challenges; and issuing a wave of enforcement activity around GLP-1 compounding, telehealth promotion, and drug/device advertising, regulatory expectations are moving quickly and leaving less room for guesswork.

The Boot Camp will provide a clear, grounded framework for how FDA is operating right now, so attendees can navigate approvals, labeling and promotion, quality and safety expectations, and emerging technologies without overreacting to headlines or underestimating risk.

Tom’s session, “CGMPs in 2026:&nbsp;Understanding FDA’s Manufacturing Rules for Medical Products, Recent Enforcement Trends, and Updates on QMSR,” will take place Thursday, March 26, from 8:30 to 9:30 a.m.&nbsp;

Quality gaps at scale in medical product manufacturing result in shortages, recalls, and enforcement risks when compliance lags.&nbsp; This session will cover the evolving set of expectations for current good manufacturing practices for medical products, including risk-based strategies for ensuring quality, and new enforcement authority for the agency.

For more information or to register, please visit the&nbsp;<a href="https://www.americanconference.com/fda-boot-camp/">event webpage</a>.

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Healthcare – Public Policy, Government Contracts Counseling & Compliance

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Thomas M. Sundlof

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CGMPs in 2026: Understanding FDA’s Manufacturing Rules for Medical Products, Recent Enforcement Trends, and Updates on QMSR

CGMPs in 2026: Understanding FDA’s Manufacturing Rules for Medical Products, Recent Enforcement Trends, and Updates on QMSR

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CGMPs in 2026: Understanding FDA’s Manufacturing Rules for Medical Products, Recent Enforcement Trends, and Updates on QMSR

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