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General interest items edited by Janice Flahiff

Looking for Biological Product Information? Try the FDA’s Purple Book

From the February 20 article at Regulatory Focus News

“Regulatory Focus: FDA Launches Searchable Purple Book. “The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product** information, known as the Purple Book. Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names (proprietary and proper), the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentation, license status, BLA number and approval date.” I didn’t know how a “biological product” was defined. I got educated via this FDA PDF.


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***What is a biological product?

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

August 17, 2020 Posted by | Finding Aids/Directories | , , , , , , , | Leave a comment

   

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