Potential distribution hitches could spark shortages of legitimate drugs if the system is not fully ready for package-level tracing requirements, US FDA says in delaying enforcement of the program a decade in the making. Poll shows supply chain partners were making significant progress in preparing for the 27 November deadline.

Warning letter details extensive GMP and data integrity remediation expectations for Matoda plant and calls for the privately held generic drug manufacturer to immediately confront its corporate quality issues globally.

Amid multinationals' accelerating de-risking and divestment moves in China, the country’s State Council has issued revised policies in the biologics manufacturing and gene therapy area, in a bid to attract foreign investment to the sector. But timely and consistent implementation will be key, an EU trade group says.