Agency IQ

AUGUST 2, 2024

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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Cytel

JUNE 19, 2024

Historically, many drugs have been prescribed to children even though this patient population have largely been excluded from clinical trials. There is an obvious logic. If medicines are to be used in children, they need to be studied in pediatric populations to ensure they are safe and effective.

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Clinical Trials Regulations Drug Research Pharmaceuticals 59

DrugBank

OCTOBER 30, 2024

At DrugBank, we’re dedicated to empowering pharmaceutical researchers with data that drives impactful results. This lets you focus on what matters most: driving meaningful results in drug research and development. In fact, poor data quality is estimated to cost U.S.

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Agency IQ

JUNE 9, 2023

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. The average annual growth in non-orphan pharmaceutical expenditure in the same period was only 3%. member states.

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Vial

MAY 20, 2024

In the field of clinical research , this pipeline can be broken down into several stages and processes specifically designed to rigorously validate the safety and efficacy of new drugs and treatments. The two broadest categories of drug development can be separated into the preclinical and clinical research stages.

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Codon

JANUARY 21, 2024

The European Medicines Agency (EMA) is similar in this regard, although interestingly, that’s not the case in the United Kingdom, where regulators are not so directly involved in assessing a challenge study beforehand. There have been deaths in phase 1 medical and drug research among healthy participants.

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Agency IQ

NOVEMBER 27, 2023

In recent years, nitrosamines, and most commonly N-nitrosodimethylamine (NDMA), have been found in finished drug products in several classes, including medicines used for diabetes, hypertension, acid reflux, and smoking cessation. [ In a study of more than 12,000 small molecule drugs , researchers found 40.4% guidelines.

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