Although a new FDA guidance recommends difference in pain scores as the primary efficacy endpoint for evaluation of postoperative analgesic effect, data on outcomes such as reduction in hospitalization and deaths from opioid abuse would be valuable and could provide a basis for inclusion in labeling; guidance is part of broader agency effort to reduce opioid use.

Commissioner Califf testifies at budget appropriations hearing that the agency may ask Congress to give it authority to require a new opioid drug application to show superiority to opioids on the market.

News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains.