Revance’s FDA Showdown
Revance Therapeutics is getting hammered today after the company flunked an inspection done by the U.S. Food and Drug Administration (FDA). 🔨
The regulator had a bone to pick with Revance’s working cell bank (WCB), which is required at the “later stages of therapeutic development and manufacturing,” according to BioReliance. The FDA said that Revance’s “Quality Unit lacks the responsibility and authority for the control, review, and approval of outsourced activities.“Â