Regulatory Focus: FDA Launches Searchable Purple Book
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.