Drugs

The Wood Burditt Group provides counsel to drug 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:

-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
-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