"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.
Biopharma companies previously requested that FDA include exclusivity information in the Purple Book, similar to what’s offered in the Orange Book, and FDA says that a later iteration of the database will include such dates...
Purple Book"
Purple Book
Tuesday, February 25, 2020
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