A new survey of U.S. biotechnology executives by the Biotech Consortium to Accelerate Innovation and MassBio reveals that while 76% of companies prefer conducting first-in-human clinical trials in the United States under predictable conditions, regulatory hurdles and delays by the U.S. Food and Drug Administration are driving them overseas. Citing costly clinical holds and procedural ambiguity, many sponsors now favor countries like Australia. To keep innovation domestic, surveyed companies recommend that the FDA clarify safety margin guidelines to set starting doses rather than treatment ceilings, restore predictable review timelines, and improve communication.

A new survey of U.S. biotechnology executives by the Biotech Consortium to Accelerate Innovation and MassBio reveals that while 76% of companies prefer conducting first-in-human clinical trials in the United States under predictable conditions, regulatory hurdles and delays by the U.S. Food and Drug Administration are driving them overseas. Citing costly clinical holds and procedural ambiguity, many sponsors now favor countries like Australia. To keep innovation domestic, surveyed companies recommend that the FDA clarify safety margin guidelines to set starting doses rather than treatment ceilings, restore predictable review timelines, and improve communication.