What Is a CRL? Why One FDA Letter Can Change a Biotech Stock
A CRL, or Complete Response Letter, is the FDA's formal way of telling a company that it cannot approve a drug application in its current form. The phrase can sound technical, but its impact is often immediate and significant. In biotech, a CRL is one of the most important negative regulatory outcomes because it signals that the application has unresolved issues and that the path to approval has become more uncertain.