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OFFICE OF NEW DRUGS MODULE

a lab mouse sitting inside a beaker

Specified biologics are a subset of biologics described in the Code of Federal Regulations. These specified biologics include therapeutic DNA-derived products, monoclonal antibodies for in-vivo use, synthetic peptides of 40 amino acids or less and therapeutic DNA plasmid products.

Most of the biologic products CDER regulates are specified biologics. These specialized biologics are exempt from general safety tests; there are more beneficial tests for specified biologics. In general safety tests, the product is administered to rodents or rabbits, and then the impact on their weight gain is assessed.

The packaging or labeling requirements are harmonized with NDA regulations for specified biologics. The official lot release is generally not implemented.

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Topic: page 4 of 4 (Lesson: page 21 of 24)