Draft guideline was issued and comments must be submitted to FDA by 6/22/2026. Let us know if anyone is interested to provide comments.
Establishing Impurity Specifications for Antibiotics | FDA
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Kim Huynh-Ba, MS, PMP, FAAPS
Pharmalytik LLC, Managing Director
Temple University, RAQA, Adjunct Professor
Illinois Institute of Technology, Adjunct Professor
[email protected]Newark DE - USA
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