Home » FDA Updates Purple Book to Include All CBER-, CDER-licensed Biologics
FDA Updates Purple Book to Include All CBER-, CDER-licensed Biologics
Drugs Regulatory Affairs
The FDA has updated its Purple Book to include information on all biologics approved by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
The agency noted that a Purple Book it released in February contained a limited data set, and the new version includes biologics regulated by CDER.
The updated book also includes product exclusivity information and a glossary.