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.
You may also be interested in...
The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.
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.
EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.