FDA Practice

Heller Ehrman has one of the largest and most comprehensive life sciences practices in the United States. For more than 40 years, we have played a pivotal role in the growth and development of innovative life sciences companies. We provide strategically focused legal and regulatory advice to pharmaceutical, biotechnology, medical device, and food companies on a broad variety of issues arising under the complex laws and regulations administered by the FDA. Our work involves counseling in matters of regulatory compliance and enforcement, as well as representation and advocacy in administrative, judicial, and legislative proceedings. We also work extensively with the private and public financing communities on leading life sciences deals, including representation of major funds investing in the life sciences.

We provide legal guidance in all aspects of business and intellectual property strategy and development, and counsel companies on corporate and securities law at each stage of development. Our regulatory attorneys guide clients through their dealings with the FDA and other administrative agencies. We assist clients in all types of collaborations, technology transfers transactions, and mergers and acquisitions. Our industry experienced litigators vigorously protect and defend patents, trademarks and other intellectual property. Our attorneys have both scientific training and business experience, which are regularly brought to bear in helping our clients to achieve practical solutions to their most difficult regulatory problems. We assist companies at all stages of a product's life cycle, including: product development; pre-clinical and clinical testing; identifying and executing optimal approval approaches; compliance with manufacturing and distribution rules; developing effective and compliant labeling, marketing, and advertising strategies; exportation and importation; and corporate and commercial transactions involving regulated companies and technologies. Our clients include large publicly traded pharmaceutical companies, private development stage drug, biotechnology, and medical device companies, and mid-size and specialty therapeutics companies, as well as venture capital companies focusing on the Life Sciences sector. Our clients' products include a wide range of marketed and investigational drugs (NCEs, generics, and "505(b)(2)" products), biologics (including peptides, recombinant proteins, vaccines, etc.), devices, and drug delivery systems, as well as foods, nutraceuticals and cosmetics.

Our experience includes:

• Assisting in determining the requirements for IND and IDE submissions and the human clinical studies required for marketing permits.
• Negotiating the terms and conditions of NDA, BLA, PMA, and 510(k) approvals or clearances.
• Preventing pre-approval and post-approval good clinical practice and good manufacturing practice compliance problems, and solving such problems before or after they are raised by FDA.
• Preparing life sciences licensing and outsourcing agreements that fully integrate regulatory operations with intellectual property and other commercial issues.
• Conducting due diligence on FDA and DEA regulatory issues for initial and follow-on public offerings, private placements, mergers, and product acquisition.
• Public and private advocacy before the FDA and Congress regarding FDA policy proposals and specific product review decisions, including the drafting of Citizen Petitions, comments to proposed regulations, and proposed legislation.

We also have substantial experience in federal litigation challenging FDA policies and specific product review decisions. Attorneys in the FDA practice group have represented clients in more than a dozen lawsuits arising under Hatch-Waxman Amendments since 1998, and in more than 20 FDA-related lawsuits over the past 10 years, utilizing the experience of seven other attorneys in the Washington office and several others firmwide who have held significant legal positions in federal agencies (including FDA, the Department of Justice and FTC).

Contacts

Natasha Leskovsek
natasha.leskovsek@hellerehrman.com
+1 (202) 912-2719

Attorneys

Charles Hungerford charles.hungerford@hellerehrman.com	Silicon Valley +1 (650) 324-7047
Christine Saunders Haskett christine.haskett@hellerehrman.com	San Francisco +1 (415) 772-6426
Jamie K. Wolszon jamie.wolszon@hellerehrman.com	Washington, D.C. +1 (202) 912-2702
Natasha Leskovsek natasha.leskovsek@hellerehrman.com	Washington, D.C. +1 (202) 912-2719
Shannon M. Bloodworth shannon.bloodworth@hellerehrman.com	Washington, D.C. +1 (202) 912-2165