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Regulatory Focus™ > News Articles > 2020 > 5 > Purple Book: FDA adds transition biologics as move to single database progresses

Purple Book: FDA adds transition biologics as move to single database progresses

Posted 12 May 2020 | By Michael Mezher 

Purple Book: FDA adds transition biologics as move to single database progresses

The US Food and Drug Administration (FDA) on Monday updated its searchable Purple Book database to include all biologics regulated by its Center for Drug Evaluation and Research (CDER) with the addition of products that transitioned from new drug applications (NDAs) to biologics license applications (BLAs) last March.
 
With the update, FDA also added the ability to download monthly reports that include a changelog detailing new and updated products from the previous month.
 
FDA explains that with the update to the Purple Book, it will no longer maintain its previous PDF-based CDER List of Licensed Biological Products. The move comes after FDA launched the searchable version of the Purple Book in February and is part of a planned transition to a single online source for licensed biological product information. (Related: FDA Launches Searchable Purple Book, Regulatory Focus 24 February 2020; BPCIA turns 10: Nearly 100 drugs become biologics, Regulatory Focus 23 March 2020).
 
FDA says that future updates to the Purple Book will add information for licensed biologics regulated by the Center for Biologics Evaluation and Research (CBER), but until then the CBER List of Licensed Biological Products will continue to be updated.
 
Once product information for all licensed biologics has been added to the Purple Book database, FDA says it will no longer update either of the PDF-based lists.
 
FDA

Tags: biologics, US

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