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Today, the Food and Drug Administration (FDA) is releasing an update to the Purple Book: Database of FDA-Licensed Biological Products to add information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER). The release will also include exclusivity information and a glossary to help provide real-time information to users about terms and other information in the Purple Book Database.
FDA will no longer update the CBER’s list of biological products. For more information about CBER regulated products, please refer to the website Licensed Biological Products with Supporting Documents.
The initial Purple Book Database (February 2020) release contained a limited data set that included all approved biosimilar products and their related reference products, with simple search and advanced search functionality. Subsequent releases added all FDA-licensed biological products regulated by CDER, FDA-licensed allergenic, cellular and gene therapy, hematologic and vaccine products regulated by CBER, in addition to a glossary, exclusivity information, downloadable monthly reports, as well as additional functionality.
The Purple Book Database is intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options, including whether there are biosimilar and/or interchangeable product options, and to advance public awareness about FDA-licensed biological products.
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