14
Jul

More DESI Drugs Bite the Dust as Final FDA Decisions Delivered in DESI Clean Up Action

Two prepublication Federal Register (FR) notices provide the backdrop for the historical demise of several products, and, with the final decision being affirmed that the products lack substantial evidence of effectiveness, they may no longer be marketed unless a New Drug Application with clinical data supporting the indications is submitted and approved. Vasodilan injection and […]

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10
Jul
RIP Headstone

PETN Dead for Good After Final DESI Hearing Decision and Exceptions Are Deemed Withdrawn

The story started in 1962 with the congressional passage of the Kefauver-Harris Amendments that added efficacy requirements for all new drug approvals.  For those products approved for safety only during the period from 1938 to 1962, an evaluation of efficacy of those products was undertaken in the Drug Efficacy Study Implementation (DESI) program.  The DESI […]

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