FDA Regulatory Practice

Clinical Trials

Quarles & Brady attorneys counsel clients on a wide array of complex issues relating to clinical trials. We regularly advise clients on both the FDA regulatory and healthcare issues presented by clinical investigations of new drugs and medical devices (including biological products regulated as drugs and medical devices). Our attorneys also have expertise in federally funded research regulations involving human subjects.

We routinely advise on such essential FDA regulatory matters as to whether an investigational new drug exemption (IND) or investigational device exemption (IDE) is required. Our counsel includes providing guidance with respect to FDA inspections of clinical investigations at academic medical centers and community based medical centers. Our attorneys assist clients in developing and implementing FDA compliance programs that include Good Clinical Practice guidelines, federal-wide assurances, research protocols, informed consent, conflicts of interest, adverse event reporting, and research policies and procedures. We advise institutional review boards (IRBs) (community-based and commercial) on compliance with FDA and other applicable regulations.

We have experience structuring collaborative clinical research arrangements among multiple institutions, IRBs, contract research organizations, site management organizations, sponsors and investigators, drafting and negotiating joint development agreements, and clinical trial contracts.

Our attorneys are experienced in compliance requirements and with federal and state statutes governing fraud and abuse in this area as well as disclosure laws required under federal and state “Sunshine Laws.” Our goal is to help clients work through the complex regulatory issues presented by the investigational studies and development of new medical technologies.