The FDA confirmed it is resuming and expanding public releases of drug rejection letters after pausing the practice earlier this year. The move comes as the agency seeks to increase transparency around application review outcomes. Separately, an FDA proposal would streamline drug establishment registration for distributed manufacturing using a “hub-and-spoke” model, reducing administrative burden by allowing a network to register as a single establishment while improving the agency’s visibility when manufacturing units move. Industry stakeholders are likely to view both actions as moving parts of the same compliance posture: publish more review decisions, while updating manufacturing registration to better reflect how modern supply chains are structured. Together, the steps could affect timelines for sponsors and CROs preparing regulatory packages and operational documentation.