Clinical Research and Product Regulation

The fastest-expanding sector within the health care industry during the past decade is the development and marketing of new prescription drugs, medical devices, and biologics. Clinical research — led by the pharmaceutical and medical device industry partnering with health care professionals and institutions — is responsible for the development of new treatments that have saved countless lives and improved the quality of life for billions of individuals worldwide.

The rapid growth of clinical research has not gone unnoticed by governmental regulators or medical malpractice attorneys. Recent lawsuits have brought research by some of the largest pharmaceutical and device companies and at some of the most prestigious institutions in the country under scrutiny by the FDA, the National Institutes of Health (NIH), the Office of Research Integrity (ORI), the Office for Human Research Protections (OHRP), and the U.S. Department of Health & Human Services, Office of the Inspector General (OIG), among others. In addition to defending these legal challenges, the clinical research community, particularly sponsors, is required to demonstrate greater diligence in complying with federal and state laws and regulations on issues ranging from protocol adherence and patient privacy to third-party billing.

Our firm has been intricately involved in representing pharmaceutical, medical device, and biologic sponsors; public and private health care institutions and research sites; IRBs; contract research organizations (CROs); site management organizations (SMOs); and principal investigators (PIs) on a variety of complex clinical research matters. In addition, several Foley attorneys currently sit on IRBs or have experience as IRB members. Foley attorneys provide ongoing assistance with a broad array of legal issues related to clinical research and the development of medical advancements.

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