Life Sciences and Healthcare Regulatory

FDA Compliance and Enforcement

Our practice routinely assists clients in achieving and maintaining compliance with respect to investigational and marketed products, handling product recalls and other crises, responding to FDA enforcement actions, and advising on the regulatory aspects of product liability and government litigation. We have assisted clients in handling complex inspections involving multiple facilities, responding to inspectional observations and Warning Letters, defending civil and criminal FDA investigations and proceedings, and negotiating favorable settlements. We have extensive experience in clinical trial enforcement issues, including assistance in FDA bioresearch monitoring inspections and handling civil penalty and disqualification proceedings. 

Our lawyers also routinely advise clients on maintaining compliance in marketing and sales issues, including review of promotional strategies and materials, including for new media. We have experience with every aspect of FDA enforcement, including both administrative and court proceedings, and our practice has a particular expertise in handling FDA regulatory issues that are the subject of simultaneous investigations by the Department of Justice, Office of Inspector General, congressional committees and state authorities, as well as collateral proceedings by private plaintiffs, in order to ensure a coordinated and effective response.


FTC Comment on FDA's Guidance on Citizen Petition Process Underscores Antitrust Risk
FDA Seeks Comments on the Regulatory Framework for Prescription Drug-Use-Related Software
Ninth Circuit Follows Escobar and Finds Lack of Materiality where Government Continued to Pay
Government Contracting Law Report, Vol. 4, No. 11
FDA's Revised Draft Guidance on Citizen Petition Process Highlights Antitrust Risk for Filers
FDA Issues Guidance Documents and Begins Drug Supply Chain Security Act Enforcement

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