With the recent publication of numerous, previously unpublished complete response letters, coupled with its plans to increase these disclosures going forward, FDA has taken a significant step forward in its previously stated commitments to transparency. FDA has framed this initiative as a way to assist drug developers in learning from prior deficiencies, to ensure that the public has accurate information regarding FDA’s assessment of applications and to strengthen public trust in FDA’s decision-making. However, applicants should be aware of these changing practices, FDA’s obligations in regard to them, and proactively consider and potentially adjust current practices in reaction to this changing landscape.
