Frommer Lawrence & Haug’s FDA Practice Group is unique. We are seasoned attorneys who not only handle a broad range of Food and Drug Administration matters, but also interact extensively with the firm’s well-known patent litigation practice, particularly in Hatch-Waxman cases for pharmaceutical manufacturers.
Several of us actually have prior experience at FDA, working on regulatory, enforcement and policy issues in the Agency’s Office of Chief Counsel, Office of the Commissioner, and Center for Drug Evaluation and Research. This has given us intimate knowledge of FDA procedures and continued contact with key FDA officials.
Our group represents a diverse group of companies in the Food, Drug, Biologic, Medical Device, Cosmetic and Dietary Supplement industries. Recently, we have focused on two new FDA areas -- Biosimilars and Tobacco products. Our attorneys routinely advise clients on matters such as Premarket Approval submissions (NDAs, ANDAs, BLAs, INDs, NDI notifications), product Labeling, Advertising and Safety requirements, Good Manufacturing Practice (GMP) standards, FDA Inspections, Recalls, and product Imports and Exports.
On the Hatch-Waxman front, we handle the numerous FDA issues arising from these cases, including Orange Book Patent Listing, NCE and Data Exclusivity, Pediatric Exclusivity, Patent Term Extensions, Authorized Generics, Bioequivalence Study Requirements, Paragraph IV Certifications and 30-month Stays, and 180-day Exclusivity (triggering and forfeiture).
The firm’s Washington, D.C. presence enables us to meet with FDA officials, attend FDA Advisory Committee meetings, and participate in public policy forums. Our group also offers in-house and external training, and maintains an active docket of presentations at national and international conferences on FDA topics.
Representative Representations
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Responses to Warning Letters
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Court Challenges to FDA Regulations
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Defense of FDA Enforcement Actions (Seizure, Injunction and Criminal Cases)
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Client Meetings with FDA for New Product Development
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Risk Evaluation and Mitigation Strategies ("REMS")
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Product Life Cycle Management Strategies
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Due Diligence in Corporate Transactions