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Good Clinical PracticeICH E6(R3) from the ground up, with a free verifiable completion record.2 courses · ~25h · Optional paid certificate

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Regulatory Review and Approval — Clinical Research Foundations

Good Clinical Practice (GCP)Course 1 of 2

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Clinical Research Foundations
Regulatory Review and Approval

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Good Clinical Practice (GCP)

Full course · Clinical Research Foundations

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Good Clinical Practice (GCP)1 of 2

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This lesson is part of a complete GCP track — 2 courses, quizzes, a final exam, and a free verifiable credential. The optional $29 PDF certificate is recognized by 18+ trial sponsors.

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Regulatory Review and Approval

Learn how drugs move from completed trials to market authorization

20 min

What you will learn7 objectives

By the end of this lesson, you will be able to:

Explain what an NDA and BLA are and what they contain
Describe the major components of a regulatory submission
Compare the different FDA expedited approval pathways
Outline the FDA review process from submission to decision
Explain what happens when the FDA issues a Complete Response Letter
Describe post-approval commitments and ongoing requirements
Recognize how the EMA centralized procedure compares to FDA approval

The evidence pillars supporting a market authorization request — FigureThe evidence pillars supporting a market authorization request

Progress saves itself — finish reading and this lesson completes