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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. Read the full list of documents on FDA’s Unified Agenda here.]

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Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

What will the orphan drug market exclusivity haircut mean for industry? Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Orphan designation in the E.U.