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FDA

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The regulatory environment created by the U.S. Food and Drug Administration (FDA) is demanding, complex and wide-ranging. Baker Donelson lawyers regularly practice in the most dynamic areas of FDA regulation, and have broad experience navigating those complexities.

Featured Experience

Assisted both seller and buyer in intellectual property aspects of acquisition of $200MM OTC pharmaceutical company by $600MM OTC pharmaceutical and household brand products company. Continue to represent combined intellectual property portfolio.

Served as co-defense counsel for spice manufacturer in action brought by U.S. Food and Drug Administration (FDA) in which the FDA sought broad injunctive relief including destruction of inventory based on violations of the Food, Drug and Cosmetic Act. In a published ruling, the U.S. District Court for the Western District of Tennessee recognized the extensive measures undertaken by the manufacturer to ensure compliance with FDA rules and regulations and that much of the relief sought by the government was largely unnecessary. 

Assisted a large pharmaceutical company in combating extensive, targeted international registrations of the client's trademarks by a foreign corporation, successfully opposing and/or obtaining assignments of all of the pirate marks, totaling roughly 100.

2015

Practice Overview

Overview

The regulatory environment created by the U.S. Food and Drug Administration (FDA) is demanding, complex and wide-ranging. Baker Donelson lawyers regularly practice in the most dynamic areas of FDA regulation, and have broad experience navigating those complexities. We take a creative approach, encouraging innovative solutions, but all based on in-depth knowledge of the issues, entities and rules and with a pragmatic, realistic application of that knowledge.

We advise established and emerging manufacturers, distributors and supply chain contributors of foods, drugs, biologics, medical devices, dietary supplements, cosmetic and personal care products, medical foods and combination products. The diverse range of activities with which we have assisted our clients includes basic regulatory compliance, advertising and claim support, strategic planning, protection of intellectual property, product liability defense and due diligence investigations.

What we believe we do best is to assist in moving clients from unknown or early development status to national or international prominence as mid-tier players. We are highly experienced in helping shape the financing and internal growth process that takes a company from a low revenue base to real economic and commercial strength. We have guided many clients along this road to success, especially in the product areas of OTC drugs, devices, dietary supplements and personal care products.

Food, Drug and Device Practice Outside the United States

In today's global economy, successful businesses look beyond geographic borders to explore new markets and resources. Baker Donelson believes that our clients benefit most from first-hand, local representation of their business goals and needs, and has therefore worked to develop an extensive international network of contacts who are knowledgeable of their own country's regulatory agencies and rules. We have well-established, ongoing relationships with local law firms around the world, in locations as diverse as Brazil, Turkey, the Netherlands and Japan, and within our practice group we have professionals with fluency in several languages, including Mandarin Chinese.

By drawing on our international contacts and internal resources, we are able to advise and guide our clients on issues related to licensing, intellectual property and import/export requirements of key world markets.

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