Comment from Mitchell Berger
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Summary: Mitchell Berger, commenting in a personal capacity, supports the proposed guidance but suggests expanding it to include cross-references for pediatric considerations, inorganic impurities, and the National Action Plan for Combating Antibiotic Resistance. He also recommends that the FDA eventually develop similar guidance for veterinary products to align with a "One Health" approach.
Dear Ms. Boam: I write to make the following suggestion with respect to the above impurity specifications for antibiotics: add a related guidances section to highlight important issues concerning potential use in pediatric populations and the need to consider inorganic impurities, cite the National Action Plan for Combating Antibiotic Resistance, and adopt a One Health approach by developing similar guidance for veterinary products once this draft guidance has been completed and finalized. Thank you for considering these comments, which reflect solely my personal views and not those of an agency, organization, or other individual(s). Full comment attached. Sincerely, Mitchell Berger