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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Electronic Regulatory Submission and Review

Data Standards in the Drug Lifecycle

Uniform Study Data Accelerates FDA Review Process

Having standard, uniform study data enables FDA scientists to explore many new questions by combining data from multiple studies. Data standards also help FDA receive, process, review, and archive submissions more efficiently and effectively.

CDER and CBER receive many kinds of data. Data standards enable FDA to modernize and streamline the review process.

Interactive “Data Standards in the Drug Lifecycle” Infographic

Click through this interactive infographic to get information about the data standards and their role in the drug lifecycle.

Contact Us

Email: CDERDataStandards@fda.hhs.gov.

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