The FDA typically takes 10 months to approve generic drugs, but actual timelines vary from weeks to years depending on drug complexity and application quality. Recent improvements using AI and priority programs are speeding up approvals.
Read MoreThe EU's generic drug market is shaped by four approval pathways, each with different timelines and costs. The 2025 Pharma Package reforms are accelerating market entry, but national inconsistencies still delay access for patients across Europe.
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