The FDA plans to make one major study, rather than two, the agency’s new default requirement for approving new drugs.

Good news! Indeed, this precautionary redundancy may not be necessary anymore or should be reserved for as few cases as possible.

"The FDA commissioner Marty Makary recently announced plans to make one major study, rather than two, the agency’s new default requirement for approving new drugs. He argued that advances in biomedical science make duplicate trials less necessary, and that the change should speed up approvals and encourage more drug development. Makary has also promised to allow more companies to sell drugs without a prescription."

"“The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products. ..."

Doomslayer: Progress Roundup - by Malcolm Cochran

FDA Drops Two-Study Rule to Speed Drug Approvals