The U.S. Food and Drug Administration (FDA) has initiated a transparency effort by publishing more than 200 complete response letters (CRLs), which are rejection letters sent to pharmaceutical companies during the drug approval process. These letters, previously mostly hidden from investors and the public, include those related to drug applications that were eventually approved. At least 14 of these letters have been made public for the first time. The FDA acknowledged that while some CRLs were disclosed as part of approval packages in the past, the information was scattered and difficult to access. FDA Commissioner Marty Makary has emphasized the importance of transparency in FDA decision-making, noting that the historical lack of openness has allowed companies to selectively present information to investors and shareholders. The release of these letters may expose the FDA to criticism but is intended to improve the agency's processes. In related developments, the FDA is considering pausing shipments of Sarepta Therapeutics' drug Elevidys following recent deaths, with FDA official Peter Marks supporting a pause to better understand safety issues. Sarepta's CEO Doug Ingram had previously claimed the company was highly transparent, though critics have challenged this assertion. Industry voices stress the need for patient-first approaches and transparency to maintain public and stakeholder trust.