The joint principles are intended to show that the FDA and the European Medicines Agency can work together as AI's use in drug research, clinical trials, manufacturing and monitoring continues to grow. “Industry always wants more certainty,” said Elizabeth Mulkey, a partner in the Technology and Life Sciences groups at Goodwin, adding that the joint release “sends a signal of certainty that globally, regulators are trying to think about this in the same way.” The joint principles aren’t binding and only reflect the goals of the US and European agencies, not the global drug development industry. But Goodwin’s Mulkey said she wouldn’t be surprised if regulators in Canada and Japan signal alignment with the joint FDA-EMA document. Mulkey said that once a precedent is established for AI use, other companies will follow suit in their own applications. The release of joint principles “sends a signal that FDA is still committed to this. Globally, regulators are committed to supporting it, but now it’s up to companies to propose things that the agencies can get comfortable with,” Mulkey said.
Read the Law360 Healthcare Authority article for more.