Products: What are they?
Any product formed
from the combination of a drug, a device and a biologic is referred to as a combination
product. Under 21 CFR 3.2 (e) this
includes two or more regulated components that are physically, chemically, or
otherwise combined or mixed and produced as a single entity.
In previous posts on this blog, our scientists have described the current state of precision medicine, particularly how it relates to companion diagnostics (CDx) and immuno-oncology. As an enterprise, we have been focused on this area of medicine essentially from the beginning, more than 20 years ago. LabCorp Diagnostics developed the clinical trials assay and served as the central lab for the testing of HER2-positive breast cancer during the development of trastuzumab. The company provided analytical testing data for the associated immunohistochemistry laboratory test resulting in the first companion diagnostic approved by the FDA. More recently, Covance was instrumental in supporting the drug development efforts for pembrolizumab, the therapy used successfully to treat former President Jimmy Carter’s melanoma, and its associated companion diagnostic. Continue reading