Therapeutic biologies

Vaccine Adverse Event Reporting System (VAERS) form. For drugs and therapeutic biologies, the MedWatch (3500A) form replaces the 1639 reporting form. 

Table 4.1 shows the major uses of therapeutic biologies, other than vaccines, in the treatment of patients suffering from various conditions. 

Biologies License Applications (BLAs) for therapeutic biologic drugs... 

At the FDA, the Center for Drug Evaluation and Research (CDER) is responsible for the approval of small molecule drugs and therapeutic biologies while nontherapeutic biologies and blood products are under the jurisdiction of the Center for Biologies Evaluation and Research (CBER). 

Patten PA, Schellekens H. The immunogenicity of biopharmaceuticals lessons learned and consequences for protein drug development. In Brown F, Mire-Sluis AR, eds. Immunogenicity of Therapeutic Biological Products. Basel, Switzerland S. Karger, 2003. 

Exposure-Response Relationships for Therapeutic Biologic Products... 

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