FDA shuts down Intar­ci­a's re­quests to de­vi­ate from typ­i­cal post-CRL hear­ing process

The FDA will go ahead with a reg­u­lar ad­vi­so­ry com­mit­tee hear­ing process for bat­tered Intar­cia’s twice-year­ly type 2 di­a­betes drug, known as IT­CA 650, and it will be the agency’s way or the high­way, ac­cord­ing to a let­ter from the FDA re­spond­ing to re­quests from the com­pa­ny to change what the FDA says are “typ­i­cal” process­es.

The re­sponse from the FDA, writ­ing on be­half of the Cen­ter for Drug Eval­u­a­tion and Re­search (CDER), was a re­ply to a May 18 let­ter from lawyers for the com­pa­ny, ask­ing the agency to “de­vi­ate from its typ­i­cal process at every junc­ture.”

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