Drugmakers seek clarity from FDA on manufacturing interruption notifications

Back in April, the FDA pub­lished draft guid­ance on when and how a phar­ma com­pa­ny can no­ti­fy the agency of an in­ter­rup­tion or halt to the man­u­fac­ture of a drug or ac­tive phar­ma­ceu­ti­cal in­gre­di­ent.

Now, drug­mak­ers are seek­ing tweaks to the doc­u­ment to bet­ter align it to re­al-world prac­tices and to bet­ter un­der­stand what the FDA wants.

Pfiz­er, for in­stance, says the FDA’s rec­om­men­da­tion for sup­ply in­ter­rup­tion up­dates to oc­cur every two weeks, even if there isn’t a change in sta­tus, might be more te­dious than worth­while:

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