It’s no secret that US drug development is a long, expensive, bureaucratic process. The average cost for a major pharmaceutical company to create a new medication in 2024 was $2.6 billion, and the job takes 10–15 years from discovery to approval, according to drug industry trade group PhRMA. To cut down on these burdens, FDA Commissioner Marty Makary told Stat on Dec. 4 the agency would change default requirements in Phase 3 clinical trials from two pivotal trials to one. While some drugs, depending on what they treat, will still require two trials, the goal is to make drug development more efficient. This rule continues previous FDA initiatives to ease the process, such as when the agency announced it would allow one trial with confirmatory evidence before approval in 2023. Biotech experts told Healthcare Brew this rule change could help bring drugs to market, but it’s also not a one-size-fits-all solution. This could be a good thing for smaller companies, particularly.—CM | 
