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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

By Sebastian Godoy, MPH , Kirsten Messmer, PhD, RAC, Corey Jaseph, MS, RAC , Kari Oakes | Oct 25, 2023 5:20 PM CDT | Updated Jul 31, 2024 10:17 PM CDT What we expect to be talking about in August and September Based on our scanning, AgencyIQ expects that August will be another sleepy summer month for European regulators.

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

Agency IQ

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. The final package, though, may well continue its focus on patient access and affordability.

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Article EMA Thank You With all nitrosamines deadlines passed, EMA updates its guidelines

Agency IQ

BY KIRSTEN MESSMER, PHD, RAC | NOV 17, 2023 4:46 PM CST Quick background on nitrosamines in global medicinal products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In a study of more than 12,000 small molecule drugs , researchers found 40.4%

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Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

Agency IQ

BY KARI OAKES AUG 7, 2023 10:20 PM CDT Quick background on nitrosamines in pharmaceutical products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In a study of more than 12,000 small molecule drugs , researchers found 40.4%

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