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Product Highlight: DrugBank on Snowflake Marketplace

DrugBank

This lets you focus on what matters most: driving meaningful results in drug research and development. Your Need for Accessible, High-Quality Data—Solved Pharmaceutical research and healthcare innovation demand timely access to comprehensive, up-to-date data.

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

Agency IQ

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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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? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.

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Deliberate Dysentery

Codon

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. There have been deaths in phase 1 medical and drug research among healthy participants. That's not coincidental.

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

Agency IQ

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. In a study of more than 12,000 small molecule drugs , researchers found 40.4% guidelines.

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

Agency IQ

drug supply, manufacturers should conclude a risk assessment of approved or marketed products within 6 months of publication of this guidance,” FDA added, with confirmatory testing intended to be concluded within 3 years. Since this discovery, it’s been unclear how regulators or sponsors might assess or address these potential risks.

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