REGULATORY COUNSELING

Frommer Lawrence & Haug's regulatory practice focuses on advising and representing clients in matters before the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the U.S. Patent and Trademark Office (PTO).

The firm has a broad FDA regulatory practice, with particular emphasis on product approvals such as New Drug Applications (NDAs), New Animal Drug Applications (NADAs) and Biologic License Applications (BLAs), and post-approval compliance on issues such as labeling requirements and good manufacturing practices. Our clients include manufacturers and distributors of pharmaceuticals, biological products, medical devices and dietary supplements.

The FTC practice centers on advertising and antitrust issues for pharmaceutical companies.

Our PTO practice, besides concentrating on patent prosecution, encompasses prosecution of trademark applications and litigation of trademark opposition and cancellation proceedings, as well as monitoring third party published patent applications and making submissions therein.

In all areas, we assist clients by planning overall regulatory strategies; monitoring, analyzing and commenting on government regulations and participating in administrative proceedings.



PRACTICE GROUPS

Patent Prosecution

Litigation

Regulatory Counseling

Trademarks & Copyrights

Licensing and Transactions

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