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Regulatory Focus Articles RSS Feed 2.0
18 January 2022
In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better postmarket ...

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18 January 2022
The EU has just kicked off a new initiative meant to transform how clinical trials are initiated and run to promote clinical research in the region. The initiative is meant to address “a relative absence of EU impactful multi-state trials” prompte...
18 January 2022
Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance on advert...
17 January 2022
A panel of former US Food and Drug Administration (FDA) commissioners, moderated by Acting FDA Commissioner Janet Woodcock, addressed the agency’s role in addressing the current and future pandemics, as well as their predictions for FDA’s near-ter...