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- Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drugWelcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.raps · 16d ago↗ source
- 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 · 16d 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…