We routinely advise on such essential FDA regulatory matters as whether an investigational new drug exemption (IND) or investigational device exemption (IDE) is required and how the FDA’s commercialization rules apply to standard-of-care products used in trials. We are also called upon to evaluate and advise on high-stakes matters presented in the context of FDA inspections of clinical investigations at academic medical centers and special considerations presented by investigations of novel technologies such as pancreatic islet cells.
In the healthcare context, clinical investigations raise challenging questions related to reimbursement. We routinely address concerns associated with whether products that have passed clinical muster will win formulary approval based on trial results and outcomes.
We are also very experienced in compliance requirements and with federal and state statutes governing fraud and abuse in this area. Moreover, as evidenced by the relatively recent proliferation of clinical trial disclosure requirements at the state and federal levels, an increasing number of government entities are becoming involved in establishing regulatory expectations for drug and medical device companies engaged in clinical research. We work to ensure that the myriad regulatory issues presented by the investigational administration of new medical technologies are thoroughly and efficiently addressed.
