U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Forms & Submission Requirements
  5. Electronic Regulatory Submission and Review
  6. Data Standards in the Drug Lifecycle
  1. Electronic Regulatory Submission and Review

Data Standards in the Drug Lifecycle

Contact us

Email:
CDERDataStandards@fda.hhs.gov.

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.

Click through the interactive “Data Standards in the Drug Lifecycle” Infographic

 
Back to Top