FDA will drop two-study requirement for new drug approvals, aiming to speed access
FDA Shifts Gears: Will One Clinical Trial Be Enough for Recent Drug Approval? The Food and Drug Administration is poised to significantly alter its drug approval process, potentially speeding up access to new medications. In a recent announcement, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad outlined plans to make a single, rigorous clinical … Read more