FDA Regulatory Practice

Regulatory Compliance and Enforcement

We regularly represent businesses in FDA compliance and enforcement matters. Our attorneys have experience with FDA inspections and in providing assistance in responding to observations and/or warning letters, and we help craft responses and corrective action programs. If your FDA regulatory compliance and enforcement matters are more complex, we can assist in injunction actions and seizures, and litigate or negotiate consent decrees so you can continue or resume product distributions. In addition to FDA compliance, drug manufacturers are required to comply with a myriad of state laws and regulations. We have a long history of successfully representing drug and device manufacturers in connection with licensure, compliance, and enforcement matters in all 50 states, the District of Columbia, and all U.S. territories.