Comment from Prateek Yadav

AnonymousSupportIndividual
Summary: The commenter supports the draft guidance as a necessary step for regulating impurities in fermentation- and semi-synthesis-derived antibiotics but argues that the scope should be expanded. They specifically advocate for including requirements to identify and control "interaction impurities" that occur in combination antibiotic drug products containing multiple active pharmaceutical ingredients.
Scope Does Not Address Combination Antibiotic Drug Products and API-to-API or API-A to Impurity-B Interaction Impurities

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