<ul data-eligibleForWebStory="false"><li>The USFDA has published more than 200 'decision letters' to provide transparency into its approval process and common deficiencies that sponsors need to address before approval.</li><li>These Complete Response Letters (CRLs) are issued by the FDA when it cannot approve an application in its current form due to safety, efficacy, manufacturing, or bioequivalence concerns.</li><li>The move aims to offer drug developers more predictability and clarity in navigating the FDA process, ensuring faster access to treatments for patients.</li><li>The decision letters are available on openFDA, redacted for confidential information, with more CRLs set to be released from the FDA's archives.</li></ul>

Drug approvals: USFDA publishes 200-plus ‘decision letters’

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