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FDA PreCheck: Incentivizing the Shift to Domestic Drug Manufacturing
US FDA launches “PreCheck” pilot to speed up construction and review of domestic drug manufacturing plants, prioritising critical medicines and modern facility technology.
What happened
The U.S. Food and Drug Administration opened requests to join its PreCheck pilot program to boost US-based pharmaceutical manufacturing by speeding up facility build-outs and FDA review. The pilot uses a 2-phase approach: early FDA engagement during design and construction, then early feedback to optimise manufacturing and quality systems before approval.
Why it matters
If FDA review becomes more…
The skinny
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