The Last Days Of PDFs: Industry Works To Solve Its US 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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Pandemic Perspectives: NCATS Director Urges Rare Disease Community To Push Against Return To Clinical Trial Status Quo
Chris Austin argued the rare disease community deserves the same “movement of heaven and earth” mentality as was employed for COVID-19.
Technologies like head-mounted tablets became critical for method transfers, virtual inspections and more. Cloud-based submissions could be next …
Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.