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