Agency IQ

AUGUST 2, 2024

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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Agency IQ

NOVEMBER 27, 2023

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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Agency IQ

AUGUST 11, 2023

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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Agency IQ

JUNE 9, 2023

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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