About

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

+ Drugs, Biologics, Medical Devices
  • PREMARKET ANALYSIS AND PLANNING
    • Hatch - Waxman Act
      • New Drug Applications (NDAs)
      • 505(b)(2) NDAs
      • Over-the-Counter (OTC) Drugs
    • Abbreviated New Drug Applications (ANDAs)
      • Patent Listings
      • Paragraph IV Litigations
      • Market Exclusivities
        • New Chemical Entity
        • Orphan Drug
        • Clinical Data
        • Pediatric Exclusivity
      • Suitability Petitions
    • Device Applications
      • 510(k) Clearances
      • Premarket Approval Applications (PMAs)
    • Combination Products
      • Risk Evaluation and Mitigation Strategies (REMS)
  • REGULATORY REVIEW
    • Clinical Holds
    • FDA Meetings
    • Advisory Committee Process
    • Complete Response Letters
    • Propietary Name Review
    • Labeling Review
  • MARKETING, ENFORCEMENT,
    LIFE CYCLE MANAGEMENT
    • Advertising and Promotion
      • Responses to FDA Warnings and Untitled Letters
      • FDA Administrative Proceedings
      • Representation in FDA Court Enforcement Actions
      • Court Actions v. FDA
      • FDA Inspections
      • Good Manufacturing Pracitces (GMPs)
      • Recalls
      • Citizen Petitions
      • Patent Term Extensions
      • Licensing
      • Due Diligence
+ Foods, Dietary Supplements
  • PREMARKET ANALYSIS AND PLANNING
    • Food Additive / Generally Recognized as Safe (GRAS) Status
    • Dietary Supplement Health and Education Act (DSHEA) Requirements
    • New Dietary Ingredient (NDI) Notices
    • Labeling Review
    • Claims Review
  • REGULATORY REVIEW
    • New Dietary Ingredient Notices
    • New Food or Color Additve Petitions
  • MARKETING, ENFORCEMENT,
    LIFE CYCLE MANAGEMENT
    • Advertising and Promotion
    • Responses to FDA Warning and Untitled Letters
    • Good Manufacturing Practices (GMPs)
    • FDA Inspections
    • Recalls
    • Representation in FDA Court Enforcement Actions
    • New Product Design / Planning
+ Cosmetics
  • PREMARKET ANALYSIS AND PLANNING
    • Formulations (Ingredients)
    • Labeling Review
    • Claims Review
  • REGULATORY REVIEW
    • Cosmetic v. Drug Classification
    • Dual Category Products
  • MARKETING, ENFORCEMENT,
    LIFE CYCLE MANAGEMENT
    • Advertising and Promotion
    • Responses to FDA Warning and Untitled Letters
    • FDA Inspections
    • Recalls
+ Tobacco Products
  • PREMARKET ANALYSIS AND PLANNING
    • Formulations (Ingredients)
  • REGULATORY REVIEW
    • Substantial Equivalence
    • New Tobacco Product Applications
    • Modified-Risk Product Applications
    • Advisory Committee Process
  • MARKETING, ENFORCEMENT,
    LIFE CYCLE MANAGEMENT
    • Establishment Registration
    • Product Listing
    • Periodic Reporting
    • Health Document Submissions
    • Responses to FDA Warning and Untitled Letters
    • FDA Inspections
    • Recalls


One way: Frommer Lawrence & Haug LLP