Re-Wiring US FDA’s Regulatory Thinking
Executive Summary
The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.
You may also be interested in...
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.
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.
US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines
Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it can use real-world data and evidence for COVID-19 vaccine evaluation.