Recent regulatory developments include Vinay Prasad’s reinstatement to additional leadership roles at the FDA’s CBER, reaffirming his influence in biologics evaluation. The FDA also issued draft guidance to encourage the development of non-opioid chronic pain treatments, specifying clinical trial frameworks and expedited pathways. Further, the FDA refuted reports about halting advisory committee meetings and continues to analyze COVID-19 vaccine safety data in children amid public scrutiny. Meanwhile, Health Canada proposes operational streamlining to reduce manufacturing red tape, and the EMA extended Emily Cooke’s mandate as its leader.