WOOD BURDITT PRACTICE AREAS

Drugs

The Wood Burditt Group provides counsel to device manufacturers, marketers, and distributors. We assist in all matters related to FDA's Center for Drug Evaluation and Research.

We assist pharmaceutical companies with all aspects of developing and marketing drug products. Our services include counseling in the areas of:

-Clinical Investigations
-New Drug Development and FDA Review Processes
-Biological Therapeutic Product Development
-Orphan Drugs
-Generic Drug Review Processes
-Over-the-Counter Drug Product Review Processes
-FDA's Post Drug-Approval Activities
-Import and Export of Human Drugs and Biologics
-Drug Registration and Listing
-Economic Assistance and Incentives for Drug Development

We advise clients on all pharmaceutical issues arising pursuant to the Federal Food Drug and Cosmetic Act (FD&C Act), as well as the various amendments to the FD&C Act, including:

Infant Formula Act of 1980

Orphan Drug Act

Drug Price Competition and Patent Term Restoration Act of 1984

Prescription Drug Marketing Act of 1987

Generic Animal Drug and Patent Term Restoration Act of 1988

Nutrition Labeling and Education Act of 1990

Prescription Drug Amendments of 1992

Prescription Drug User Fee Act (PDUFA) of 1992

Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994

FDA Export Reform and Enhancement Act of 1996

Animal Drug Availability Act of 1996

Food and Drug Administration Modernization Act (FDAMA) of 1997

Best Pharmaceuticals for Children Act

Animal Drug User Fee Act of 2003

Pediatric Research Equity Act of 2003

Minor Use and Minor Species Animal Health Act of 2004

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Food and Drug Administration Amendments Act of 2007