Deeona R. Gaskin

DEEONA GASKIN advises life sciences, medical device, digital health, food and cosmetic companies on FDA regulatory, compliance, and enforcement matters worldwide. She formerly served as an Associate Chief Counsel at the U.S. Food and Drug Administration (FDA).

Deeona regularly counsels clients on good clinical practice (GCP), current Good Manufacturing Practice (cGMP), and Quality Management System Regulation (QMSR) compliance, data integrity, product recalls, and adverse event reporting matters, and also represents companies in Federal Food, Drug, and Cosmetic Act (FDCA) and False Claims Act (FCA) enforcement actions and investigations.

Her practice includes advising on digital health and artificial intelligence/machine learning technologies, marketing applications, chemistry, manufacturing, and controls (CMC) issues, clinical holds, hazard analysis, and critical control points (HAACP), and corporate transactions involving FDA-regulated products. Deeona also advises on recall strategy and communications, and on protecting trade secrets and confidential commercial information from public disclosure under the Freedom of Information Act (FOIA) and FDA regulations.

Deeona also prepares pharmaceutical, biologic, medical device, combination product, and food manufacturers for FDA pre-approval, pre-licensing, and surveillance inspections, including on-site readiness assessments. She assists clients in responding to Form FDA 483 observations, Warning Letters, Import Alerts, Additional Information Requests, and Complete Response Letters.

While she was at the FDA as Associate Chief Counsel, she worked in conjunction with the Department of Justice (DOJ) to bring enforcement actions (including injunctions and seizures) involving foods, dietary supplements, medical devices, and drugs, and personally negotiated many consent decrees. She also helped to defend the agency against lawsuits involving citizen petitions, import alerts, and the Hatch-Waxman Amendments. During her time at the FDA, she received numerous awards, including the Department of Health and Human Services’ Office of the General Counsel Outstanding Newcomer Award.

Chambers USA, which recognized her for Healthcare: Pharmaceutical/Medical Products Regulatory in District of Columbia (2023–2025), highlighted that “Deeona truly understands business needs and concerns and gives extremely helpful and practical advice” and that “Deeona is proactive and attentive.”

Deeona's representative matters include:

• Providing strategic guidance concerning marketing applications and CMC issues
• Advising clients regarding GCP and clinical holds
• Providing regulatory and compliance guidance regarding digital health and AI technologies
• Preparing clients for pre-approval and pre-licensing inspections
• Preparing pharmaceutical, medical device, gene therapy, combination product, and food manufacturers for regulatory inspections through on-site guidance
• Assisting clients on responses to FDA Form 483s, Warning Letters, and import alerts
• Representing clients in government investigations pursuant to the False Claims Act
• Advising clients in internal compliance investigations
• Performing data integrity assessments for clients in Asia, Europe and the United States
• Preparing recall communications for healthcare providers
• Advising clients on strategies to protect trade secrets and confidential commercial information from public disclosure under the Freedom of Information Act (FOIA) and FDA regulations
• Counseling clients on FDA regulatory issues related to corporate sales and reorganizations

Deeona represents clients in applications for asylum, permanent residence and work authorization. She serves on CAIR Coalition’s Board of Directors.