Previous public health crises have changed medical product development and regulatory practices. These examples include major legislative amendments and creative application of regulatory paradigms to address HIV, anthrax and other bioterrorism threats, and infectious diseases. 1  To address the threat of COVID‐19 and simultaneously ensure continuity of development of non‐COVID‐19 treatments, regulators are providing significant regulatory flexibility while maintaining the high standards for quality, safety, and effectiveness. As Rasmus Hougaard argued in a recent Forbes article, “The heat of a crisis creates a burning platform, propelling organizations and individuals to make pivots and changes that seemed too hard or overwhelming during normal times.” 2