'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has re­ject­ed Ver­ri­ca Phar­ma­ceu­ti­cals’ skin dis­ease treat­ment for a third time — and once again the con­tract man­u­fac­tur­er is to blame.

The biotech em­pha­sized that the on­ly de­fi­cien­cy in the com­plete re­sponse let­ter is re­lat­ed to a gen­er­al rein­spec­tion of the CMO, Ster­ling Phar­ma­ceu­ti­cals, and has noth­ing to do specif­i­cal­ly with its drug-de­vice; the rest of the NDA is good to go.

CEO Ted White said the com­pa­ny is “ex­treme­ly dis­ap­point­ed,” but will keep work­ing to­ward ap­proval.

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