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Back in April, the FDA published draft guidance on when and how a pharma company can notify the agency of an interruption or halt to the manufacture of a drug or active pharmaceutical ingredient.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