FDA Databases (U.S.)

PurPLE Book

The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER). The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER). Click HERE to access.

Vaccine, Blood & Biologics

Direct link. Click HERE to access.

Approved Cellular and Gene Therapy Products

Direct link. Click HERE to access.

Drugs@FDA

The FDA’s searchable database of approved drugs, including biologics and biopharmaceuticals. It provides approval letters, labels, and regulatory history. Click HERE to access.

EMA DataBAses (E.U.)

EMA MEdicines Database

The central portal for all medicines authorized via the EMA’s centralized procedure. It includes detailed product information, summaries of product characteristics, package leaflets, and regulatory history. Click HERE to access.

National Registers of Authorized Medicines

Each EU/EEA member state maintains its own register, linked through EMA. These provide complementary information for medicines authorized per nation state. Click HERE to access.