Complete Response Letter (CRL)

A Complete Response Letter (CRL) is an official communication from the U.S. Food and Drug Administration (FDA) issued to a drug or biologic sponsor at the conclusion of the review process when the application cannot be approved in its current form. The CRL outlines the specific reasons for non-approval and provides detailed guidance on the deficiencies that must be addressed before the product can be reconsidered for approval.

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Quality & Compliance

FDA Publishes over 200 Complete Response Letters (CRLs)

On July 10th, 2025, the FDA announced its decision to publish over 200 Complete Response Letters (CRLs) issued between 2020 and 2024. This decision marks a seismic shift in the way our industry...

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Regulatory Sciences

FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know

A New Era of FDA Disclosure On Thursday, July 10, 2025, FDA published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications...

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How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors

How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...

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