Breakthrough Designation Is A Two-Way Street, FDA Cautions Sponsors

Sponsors of would-be breakthrough therapies need to move as quickly as FDA is acting, from responding to emails to ramping up manufacturing so they can start trials earlier.

Neither the first breakthrough therapy designees nor FDA seemed prepared for the operational tempo that was required for the pathway, which has prompted the agency to begin laying out communications expectations for the program.

Ironically, some early breakthrough programs did not include as much dialogue between the agency and sponsor as the concept promised....

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