Re-Wiring US FDA’s Regulatory Thinking
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...
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.
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.
US Senate hearing on pharmaceutical competition brought renewed interest to idea of pruning so-called ‘patent thickets.’ But the choking growth of legislative proposals may itself by hampering progress on Capitol Hill.