Xellia Pharmaceuticals, Inc.

FDA Draft Guidance on Fermentation-Derived Antibiotics Sparks Industry Calls for Global Harmonization

- FDA released a draft guidance setting impurity controls for antibiotics produced via fermentation or semi-synthetic methods, addressing a longstanding regulatory gap. - The guidance provides recommendations for identifying, qualifying, and managing impurities and degradation products, referencing ICH Q3A(R), Q3B(R2), and M7(R2) frameworks. - Industry groups including AAM, PDA, Pfizer, and Xellia have urged FDA to harmonize terminology and thresholds with EMA and ICH guidelines to reduce regulatory uncertainty. - Stakeholders highlighted that EMA already provides specific thresholds for fermentation products, and inconsistent FDA reviewer approaches may hinder global drug development programs.