AAPS normally doesn't have a lot of discussion on antibiotics, but for those who work in this space, the Agency just released a new draft guidance "Establishing Impurity Specifications for Antibiotics".
From the announcement:
"The draft guidance provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. This draft guidance applies to antibiotic drugs subject to approval under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and associated type II drug substance drug master files (DMFs) referenced in antibiotic NDAs and ANDAs. This guidance also applies to nonprescription antibiotic drugs, often referred to as over-the-counter (OTC) monograph drugs."
#fda #DraftGuidance #antibiotic
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-impurity-specifications-antibiotics
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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