DBE CDER Meaning and
Definition
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DBE CDER stands for Drug Biologic Expedited Clinical Development and Review, which refers to a regulatory process of the U.S. Food and Drug Administration (FDA) for the accelerated development and review of certain drugs and biologics.
The term "drug" encompasses pharmaceutical compounds, while "biologic" includes a wide range of therapeutic products derived from living organisms or their components. The DBE CDER process is designed to facilitate the expedited assessment and approval of such products, particularly those intended to treat serious or life-threatening conditions with unmet medical needs.
This regulatory pathway enables manufacturers to submit data and evidence from early stages of clinical development to support the accelerated review of these products. It aims to streamline the development and review process by providing early feedback and guidance to sponsors regarding their products' safety, efficacy, and potential benefit-risk profile.
Through the DBE CDER program, the FDA collaborates closely with manufacturers to ensure that the necessary preclinical and clinical data are generated, analyzed, and submitted in an efficient manner. This approach allows for more timely regulatory decisions and facilitates patient access to innovative therapies that may offer significant medical advances.
Overall, DBE CDER is an expedited clinical development and review process employed by the FDA to accelerate the approvals of drugs and biologics for serious or life-threatening conditions, ultimately aiming to improve patient care and public health outcomes.
Common Misspellings for DBE CDER
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