Maarika Kimbrell

WORK HISTORY

EDUCATION

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ABOUT MAARIKA KIMBRELL

I focus my practice on FDA regulation of drug and biologic products, advising life sciences companies on complex regulatory and related commercial matters across the product lifecycle. Drawing on my experience in FDA leadership roles, I bring a practical, insider understanding of the agency’s regulatory framework and decision-making.I advise clients on mission-critical issues affecting product development strategy, FDA engagement, regulatory risk, and FDA enforcement and litigation, including resolving complex and novel regulatory issues before the FDA and representing clients in adversarial matters.With clients ranging from multinational pharmaceutical companies to emerging biotechnology companies, manufacturers, developers, and investors, my experience spans premarket and clinical development strategy, FDA submissions and meeting strategy, post-approval filings, inspections and recalls, development incentives (including exclusivities and vouchers), and biosimilar and generic drug programs under the Hatch-Waxman Amendments and the Biologics Price Competition and Innovation Act. I also counsel clients through business-critical FDA enforcement actions, adverse regulatory decisions, and product withdrawals.The statements and views expressed in my posts are my own and do not reflect those of Morgan Lewis.