Navigating the Shifting Regulatory Sands of the EMA and FDA

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2025-12-23 10:11:08 -

How are new safety guidelines impacting time-to-market for new molecules? Regulatory bodies have significantly tightened their requirements for clinical trial diversity and long-term safety data. For pharma developers, this means that the "fast-track" approvals common in the early 2010s are becoming rarer. Success in 2024 requires a proactive regulatory strategy that incorporates real-world...

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