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- Euro Roundup: EMA posts guidance on preventing microbial contamination of non-sterile productsThe European Medicines Agency (EMA) has released guidance on technical and organizational measures that companies should consider to prevent microbial contamination of non-sterile products.raps · 13d ago↗ source
- CDER plans new guidance on AI, electronic safety report submissions, and moreThe US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…raps · 13d ago↗ source
- Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentivesPatient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any…