Friday, August 25, 2023

What is purpl book of US FDA ?

The Purple Book database is a comprehensive resource that contains information about various FDA-licensed biological products. These products are under the regulatory oversight of two different centers within the FDA:

Center for Drug Evaluation and Research (CDER):

This center regulates FDA-licensed biological products, including biosimilar and interchangeable products, along with their reference products. These products fall under the category of biological drugs.

Center for Biologics Evaluation and Research (CBER):

The Purple Book also includes information about FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products. These products are regulated by the Center for Biologics Evaluation and Research. They encompass a range of biological products, including those used for allergy treatment, cellular and gene therapies, blood-related conditions, and vaccines.

The Purple Book provides a user-friendly interface for searching and accessing information about these biological products. Users can search for a product using either its proprietary (brand) name or its nonproprietary (proper) name. As users type their query into the search box, the interface offers a list of potential results that starts to appear below the search box. This auto-populated results list assists users in finding the desired product quickly.

By clicking on a product from the results list, users can access the results page for that specific product. On this results page, users can find information about all biological products that share a core name. This includes not only the selected product but also related products such as biosimilars, interchangeable products, reference products, and other relevant biological products.

In essence, the Purple Book serves as a valuable resource for individuals seeking information about FDA-licensed biological products, offering a convenient way to access details about various biological drugs, allergenic products, cellular and gene therapies, hematologic products, and vaccines.

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