The FDA has announced significant changes aimed at expediting the review process for drugs and medical devices. In a move aligned with previous efforts to minimize bureaucratic hurdles, the agency has eliminated barriers to utilizing real-world evidence in application reviews. This shift includes plans to accept de-identified real-world data for specific medical device applications and a commitment to implement rapid drug review programs alongside real-time decision letter publications. The FDA has also called for reforms in early-phase trials to enhance the use of real-world evidence. While some celebrate these changes as a progressive step towards speeding up new cures, concerns remain regarding the potential lowering of drug-approval standards.