Updates to FDA’s Purple Book: Database of Licensed Biological Products

According to FDA, Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available. ⁽¹⁾

This week’s update includes the addition of all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER) including those which have been approved in new drug applications (NDAs) and were “deemed to be licenses” under section 351 of the Public Health Service Act on March 23, 2020. CDER will no longer continue to update the CDER List of Licensed Biological Products, since they can now be found in the Purple Book.

Upcoming releases will include FDA-licensed biological products regulated by Center for Biologics Evaluation and Research (CBER), and once included, FDA will no longer update the CBER List of Licensed Biological Products which is currently still being maintained. Below is a link to the Purple Book on FDA’s website:

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1. United States Food & Drug Administration. “What Are “Biologics” Questions and Answers.” https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers. Accessed May 15, 2020