Gail E. Radcliffe, Ph.D., is President of Radcliffe Consulting, Inc. (RCI), a team of regulatory, clinical, and business experts that guide IVD (in vitro diagnostic) manufacturers through the complex process of navigating U.S. Food and Drug Administration and European Union regulations to bring their regulated products to market. The company offers regulatory strategy and submission drafting, clinical trial conduct, and assistance with quality system development and implementation.
In this question-and-answer article, Radcliffe discusses the IVD market with Healthcare Packaging.
Healthcare Packaging (HCP): When it comes to in vitro diagnostics from a medical treatment standpoint, how important are IVDs and what should enthuse the general public about IVDs?
Gail Radcliffe: IVDs are extremely important. Most treatment decisions are based on diagnostic product results. Companion diagnostics kick the bar up even more. Companion diagnostics determine whether or not a patient should be treated with a particular drug and if so whether the dosage will be safe for that person.
