FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

FDA Drug Approval Process

U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.

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