The International Council for Harmonization (ICH) has released a draft Q3E guideline that offers a harmonized framework for assessing and controlling extractables and leachables (E&L) in ...

The UK has set out plans to get new medicines to patients three to six months sooner by coordinating regulatory and reimbursement processes.

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Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US FDA Chief Says He Wants Gene Therapy Head Prasad to Return (Bloomberg) US to initially impose 'small ...