Food & Drug Administration (FDA)

Nexsen Pruet attorneys have strong backgrounds in science and technology, which help us assist clients in complying with Food and Drug Administration (FDA) regulations. We also assist companies with FDA inspections, Hatch-Waxman issues, licensing needs, and other FDA related matters.

Our project experience includes:

• Cosmetics
• Generic Drugs
• Grandfathered Drugs
• Investigational New Drugs
• Medical Devices
• New Drugs
• Orphan Drugs

In addition we have also provided assistance with other federal administrative agencies including:

• Department of Transportation
• Environmental Protection Agency
• Bureau of Alcohol Tobacco and Firearms
• Occupational Safety and Health Administration
• Department of Agriculture
• Drug Enforcement Administration

We help our clients understand the laws and regulations applying to their industry areas, obtain permits or licenses required by these agencies, and handle inspections conducted by these agencies.