Cathy Burgess and Dan Jarcho spoke at the annual Enforcement, Litigation, and Compliance Conference sponsored by the Food and Drug Institute (FDLI).
Cathy moderated the panel “Data Integrity: Quality by Design, Comparability Data, and the Application Integrity Policy.” The session focused on recent FDA compliance and enforcement trends regarding data integrity in clinical research, marketing applications, and commercial manufacturing.
Dan spoke on the panel “An Assist for Litigants Challenging Governmental Actions: Implications of the Supreme Court’s Decision on Agency Deference.” The panel discussed litigation challenging FDA actions under the Administrative Procedure Act and the potential implications of the Supreme Court’s recent decision about agency deference in Kisor v. Wilkie.
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