In addition to the full range of intellectual property services, Boulware & Valoir has considerable experience in the Food and Drug Administration (FDA) regulated industries and can offer counseling and education on many aspects of food, drug and cosmetic law.
Understanding both the FDA and patent law allows us to assist clients in designing FDA and patent strategies that complement each other to provide the most effective market exclusivity. For more information on this topic click here.
Our services have included counseling on:
- Import/export of food
- Import/export of hazardous biologicals
- Import/export of cosmetics
- Import/export of drugs, biological and medical devices
- Hatch Waxman patent term extensions
- Paragraph IV certification litigation
- General regulatory scheme for medical device clearance or approval
- General regulatory scheme for drug and biological approval
- Advice on patent and FDA strategies
- 510K, PMA, and Orange book searches