Desi status Guide

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FAQ Desi status

What does Desi stand for?

Drug Efficacy Study Implementation (DESI) FDA’s administrative process to consider the effectiveness of drugs that had been approved only for safety between 1938 and 1962 is called the drug efficacy study implementation (DESI).

Are all Desi proceedings closed?

Most DESI proceedings have been closed and FDA’s findings have been published in the Federal Register.

What happens after FDA’s final Desi determination?

If FDA’s final DESI determination classifies a drug as lacking substantial evidence of effectiveness, the agency will provide notice of an opportunity for a hearing. The agency considers these requests and either grants or denies it.

Can a drug remain on the market during an open Desi proceeding?

A few DESI proceedings remain open without a final decision or resolution. It is the agency’s policy that drugs subject to an open DESI proceeding may remain on the market during the proceedings.