After 50+ Years, FDA Finalizes DESI Notice on Estrogen-Androgen Fixed Combination Drug Products
The Federal Register (FR) notice (here) appearing on today’s pre-publication page describes the long and tedious process of finalizing one of the last remaining Drug Efficacy Study Implementation (DESI) notices, and ends with a final FDA decision that there is a lack of substantial evidence of efficacy for the use of certain estrogen-androgen fixed combination […]
