All Technology articles
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Industry newsFDA's Emerging Technology Programme
The FDA’s Emerging Technology Programme intends to assist industry in gaining regulatory approval for innovative technology drug applications.
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Industry newsEU seeks to boost innovation ahead of future pandemics
Following the impact of the COVID-19 pandemic, an EU-funded team has created an online platform for the development of diagnostic, prevention and surveillance technologies for emerging novel diseases.
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FocusHow data remediation and stewardship is becoming a standard responsibility for regulatory operations professionals
Data quality is becoming increasingly critical to the success of medicinal product applications and has the potential to increase the speed and efficiency of medicines supply to patients. There is an industry move towards a data-driven regulatory enterprise, highlighted particularly through the arrival of initiatives such as identification of medicinal products (IDMP), real world evidence (RWE), digital application dataset integration (DADI), electronic product information (ePI), marketing status (IRIS), US FDA knowledge-aided assessment and structured application (KASA) and eCTD 4.0, among others.