MAB CDER stands for "Monoclonal Antibodies and Combination Products Division" and refers to a specific division within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). CDER is a regulatory agency responsible for ensuring that pharmaceutical drugs are safe, effective, and properly labeled for use in the United States.
The MAB CDER division focuses specifically on the review and regulation of monoclonal antibodies (MABs) and combination products. Monoclonal antibodies are laboratory-produced proteins that mimic the immune system's ability to fight off harmful pathogens, cancer cells, and other diseases. They are often used in the treatment of cancer, autoimmune disorders, and certain infectious diseases.
Combination products, on the other hand, refer to therapeutic products that combine two or more different types of components, such as drugs, devices, or biological products. These products have unique regulatory challenges as they involve multiple parts and are subject to different regulatory requirements.
The MAB CDER division is responsible for evaluating the safety, efficacy, and quality of monoclonal antibodies and combination products through a rigorous review process. They assess pre-market applications, review clinical trial data, and provide guidance to manufacturers regarding proper labeling, manufacturing practices, and post-marketing surveillance.
Overall, MAB CDER plays a crucial role in ensuring that monoclonal antibodies and combination products meet regulatory standards, thereby protecting public health and promoting the development and availability of safe and effective pharmaceutical therapies.
