Jennifer M. Nowak is a Washington, D.C., attorney and a member of Holland & Knight's Public Policy and Regulation Group. Ms. Nowak's practice focuses on regulatory compliance and advocacy, with a particular emphasis on aviation law, as well as food and drug law.
In her aviation law practice, Ms. Nowak advises airlines, airports, aviation service providers and other clients on a wide range of regulatory matters relating to safety and economic licensing, unfair and deceptive trade practices, consumer protection, international air service agreements, antitrust immunity and hazardous materials compliance. In her food and drug law practice, Ms. Nowak advises healthcare and life sciences clients on U.S. Food and Drug Administration (FDA) and healthcare regulatory, compliance and enforcement issues.
Ms. Nowak regularly represents clients in rulemaking, enforcement and other regulatory proceedings before the U.S. Department of Transportation (DOT), Federal Aviation Administration (FAA), Transportation Security Administration (TSA) and U.S. Customs and Border Protection (CBP). She routinely assists international airline clients with the launch of service to the United States, advising not only on U.S. licensing but also on related transactional matters, such as contract review and negotiation, and providing ongoing counseling on myriad pre-launch and post-launch regulatory and compliance obligations.
Ms. Nowak has extensive experience in advising clients in the construction and wind energy industries regarding FAA airspace obstruction evaluation regulations and policy as well as airport and local government land use issues. She supports clients with regulatory filings and assessments to ensure compliance with air space limitations, as well as counsels clients on mitigation strategies for noncompliant projects or structures.
Additionally, Ms. Nowak advises clients from diverse industries interested in operating unmanned aircraft systems (UAS, or "drones") for commercial purposes on regulatory and operational compliance, supports them through the FAA waiver and exemption processes, and works with clients to develop strategies for conducting fully compliant operations that meet their needs.
Prior to joining Holland & Knight, Ms. Nowak was an analyst at an aviation consulting firm, where she advised clients in the construction and wind turbine industries regarding FAA obstruction evaluation regulations and policy. She supported clients throughout the FAA obstruction evaluation process, including performing in-depth analyses of imaginary surfaces and terminal procedures requirements on a case-by-case basis, including mitigation of noncompliance.
Ms. Nowak is a co-editor and regular contributor to the Holland & Knight Aviation Law Blog.
Ms. Nowak regularly advises pharmaceutical, medical device, biologic, dietary supplement, cosmetic and food distributors and manufacturers on pathways to market and pre-market requirements, labeling, advertising, clinical investigations, quality systems requirements and post-marketing requirements.
Ms. Nowak counsels clients through FDA inspections and post-inspection proceedings, and represents them before the FDA on enforcement and compliance issues, regulatory policy matters and during user fee negotiations. She also drafts healthcare legislation and legal analyses in support of client legislative and regulatory advocacy efforts.
In addition, Ms. Nowak routinely performs due diligence services for corporate clients to evaluate regulatory compliance risks in commercial transactions involving FDA-regulated products.
Ms. Nowak provides commentary on food and drug law issues for the Holland & Knight Healthcare Blog.
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