The US Food and Drug Administration (FDA) has launched a pilot program that will share information from several recent product approvals aimed at helping scientists, companies and the public understand how the agency arrives at its approval decisions. FDA Commissioner Scott Gottlieb announced the initiative at a forum on FDA transparency held January 16 at Johns Hopkins Bloomberg School of Public Health. The agency will make public selected clinical information related to up to nine recently approved drugs. The drug makers voluntarily signed up to the program and agreed to provide detailed summaries, or 'clinical study reports' (CSRs), containing methods and results of the clinical reports submitted to the FDA. The pilot program comes after calls in recent years for regulators to be more transparent through release of clinical data (Nat. Biotechnol. 32, 528–535, 2014). “We expect that making a CSR publicly available after a drug's approval will provide stakeholders with more information on the clinical evidence supporting a drug application and more transparency into the FDA's decision-making process,” Gottlieb said in a statement. In his January 16 speech to the forum, the commissioner also said the agency is looking to “release additional information from complete response letters (CRLs) related to clinical safety and efficacy that could have significant public health value.” CRLs are sent by the agency to manufacturers informing them that their drug application is not yet ready for approval. At his April 2017 confirmation hearing, Gottlieb said that he was open to releasing partially redacted CRLs to enhance transparency. Jordan Hindson