FLH's FDA/Regulatory Group includes a unique blend of seasoned FDA attorneys, who not only have a direct working history at FDA, but also practice a variety of intellectual property matters of the firm, including its renowned Hatch-Waxman patent litigation and patent and trademark prosecution. While at FDA, members have worked on virtually every FDA-regulated product-class from a regulatory, enforcement, and public policy perspective spanning from the 1970s to 2000s in FDA's Office of Chief Counsel, Office of the Commissioner, and Center for Drug Evaluation and Research. As a result, members have continued to interact with all of FDA's centers, including the Office of Global Regulatory Operations and Policy (Compliance). The Group also features a former professor of FDA Law at the New York University School of Law for 30 years and offers in-house and external training, including an active docket of presentations at national and international conferences featuring FDA-oriented topics, often coupled with intellectual property-related matters.

Both senior and more junior members have effectively represented a diverse and engaging group of companies in the food, drug, biologic, medical device, or cosmetic and dietary supplement industries. In addition, the Group has represented its clients before FDA and at all levels in the federal courts, when necessary, to advocate for its clients' positions.

The FDA/Regulatory Group's deep FDA and industry knowledge base permits it to handle not only all FDA-regulated products, including new areas such as biosimilars and tobacco, but also combination products, in an uncommonly-productive way that benefits its clients. Some of the Group's recent services include pre-market approval applications (NDAs, ANDAs, BLAs, INDs, and NDI notifications), product claims and labeling, product advertising and promotion, good manufacturing practice requirements, FDA inspections, product safety issues, prescription drug user fees, and regulation pertaining to imports and exports. FLH's Washington, D.C. office interfaces with FDA officials on a regular basis and participates in FDA's advisory committee and industry meetings, as well as hearings and public policy meetings, at all Federal levels.

The depth of experience of our FDA/Regulatory Group, coupled with proactive, responsive, and effective service, continues to make the Group a proven leader in FDA law.

Representative Matters

• Federal Circuit, D.C. Circuit, and lower court proceedings in the FDA regulatory area, including statutory interpretations of use codes and related regulatory issues stemming from FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known at "the Orange Book").
• Litigation support for Hatch-Waxman (patent) and transactional cases that include FDA-regulated products.
• Administrative hearings before FDA.
• Responses to FDA's Warning and untitled enforcement letters, including working with Agency officials as appropriate, typically following an inspection, recall, or seizure.
• Industry meetings with FDA for new product development, including orphan drugs and other special category products or products with additional regulatory measures such as Risk Evaluation and Mitigation Strategies ("REMS") or other risk management programs.
• Life cycle management product development strategies, including recommendations for hybrid products such as 505(b)(2) NDAs or combination products.
• Due diligence research and reports, frequently involving confidential documentation in protected reading rooms, for new product or company acquisitions or sales.