| Licensed products are biological products that have been
determined by FDA to be safe, pure, and potent. Biological products,
once licensed, may be marketed in the United States. Some biological
products are regulated by CDER, while others are regulated by CBER.
Licensed biological products are subject to BLAs (biologic license
applications). Approved drug products have been determined by FDA to
be safe and effective. Approved drugs (regulated by CDER) have been
evaluated and reviewed by CDER for safety and effectiveness and may
be marketed in the United States. Approved drugs are subject to the
following types of drug applications: NDA (new drug application) and
ANDA (abbreviated new drug application).
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