FDA Regulations

LimNexus advises exporters, importers and distributors on the sales, manufacture, export and import of FDA regulated products including medical equipment, personal protection equipment, food, cosmetics, tobacco, and other regulated products.

Matter List

• Represented and advised biotech companies on their FDA registration. Advised exporters of PPEs and FDA regulated medical devices to the United States including Emergency Use Authorization; represented and advised clients on FDA holds and releases at the border.

Attorneys: T. James Min II, Nicholas M. Roegner, Brianna M. Krominga, Chelsea Ellis

Related Practice Areas:

• International Trade & Regulatory Compliance
• Export Controls
• Primary and Secondary Economic Sanctions
• Free Trade Agreements
• Customs Regulations
• eCommerce
• CFIUS
• Anti-bribery Law
• Internal Corporate Compliance