Drug regulation articles from across Nature Portfolio

Drug patents are different. To improve their quality ex ante, regulators can use predictive models.

In 2022, the FDA approved numerous new drug and biologic agents, including targeted small molecules, immunotherapeutics, a gene therapy and a radiopharmaceutical. Several drug development challenges were also addressed, and key focus areas for the FDA Oncology Center of Excellence included ongoing monitoring of the Accelerated Approval programme and drug dose optimization.

Designing technology for point-of-care use in low- and middle-income countries requires understanding of the underlying barriers that contribute to recalcitrant global problems. The only way to understand those barriers is to work with local experts, otherwise you may wind up solving the wrong problem.