FDA will drop the two-study requirement for new drug approvals, setting one-study as the default to speed access

FDA Commissioner Marty Makary and deputy Vinay Prasad say the agency will shift its default approach for new drugs and other novel health products to require only one clinical study instead of two. The change is presented as part of a broader effort to speed access to medicines by reducing bureaucracy, supported by the claim that modern drug research is more precise and scientific. The policy also highlights a contrasting stance inside the FDA: Prasad’s vaccine division recently rejected and then later accepted Moderna’s mRNA flu shot application after it conducted an additional study in older people, and Prasad has rejected some experimental gene therapies and biotech products for needing more definitive evidence.