PDF's Last Days In US: Industry Works To Solve Its FDA Application Problem
The goal is a platform where sponsors could enter data that multiple regulators could view in real-time, rather than rely on ‘digital paper’ – pdfs and other static file formats that require health agencies to reenter the data in order to analyze it.
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Re-Wiring US FDA’s Regulatory Thinking
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US FDA’s Data Strategy Under Increasing Pressure From Coronavirus Pandemic
As agency prepares to hear from stakeholders on its strategy, real-world data precedents already are being set thanks to COVID-19, Aetion tells the Pink Sheet.
Pediatric Study Plans For Coronavirus Therapies To Get Trans-Atlantic Streamlining
EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.