The U.S. Food and Drug Administration (FDA) regulates the sale of foods,
pharmaceuticals, medical devices, dietary supplements, cosmetics and veterinary
products. ST&R’s skilled attorneys and consultants assist domestic and
international clients in meeting all regulatory requirements for the approval /
clearance for sale of FDA-regulated products. This includes preparing:
- New drug applications (NDAs): for approval of pharmaceuticals new to the U.S. market;
- Abbreviated New Drug Applications (ANDAs): for approval of a generic drug;
- 510(k) Pre-market Application: for FDA pre-market clearance of a new medical device
If you have developed or seek to import a food, beverage or dietary supplement new to the U.S. market,
ST&R will assist you with all FDA compliance matters, including labeling and packaging materials for
foods, drugs, cosmetics, beverages and dietary supplements; facilities inspections; recall procedures;
product listing and establishment registration; responding to FDA warning letters; and compliance with
Food Safety Modernization Act (FMSA) requirements.
ST&R can assist you in FDA registration, compliance and enforcement matters related to:
If you require assistance with an FDA-regulated product, please contact us at
fda@strtrade.com.