Industry leaders are urging the U.S. Food and Drug Administration (FDA) to strike a balance in its approach to AI regulation in the pharmaceutical and medical device sectors. At the RAPS Regulatory Intelligence Conference, experts emphasized the need for flexibility and collaboration over rigid rules, warning that overly prescriptive regulations could hinder innovation. They also highlighted the importance of clearly defining AI goals within the industries and making strategic investments.
Key takeaways:
- Argentina's President Javier Milei is positioning his country as a potential hub for AI investment, capitalizing on regulatory shifts and restrictive regulations in the U.S. and Europe.
- The 5th U.S. Circuit Court of Appeals has decided not to adopt a rule regulating the use of generative AI by lawyers, keeping its courtrooms strictly human for now.
- Industry leaders at the RAPS Regulatory Intelligence Conference have urged the FDA to adopt a balanced approach to AI regulation, advocating for flexibility and collaboration over rigid rules.
- Despite varying opinions on AI's readiness, there is a consensus that precise goals and strategic investments are crucial for leveraging AI's full potential in the pharmaceutical and medical device sectors.