This article was originally published in SRA
US Supreme Court refuses appeal hearing on Andrx antitrust ruling
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Experts including renowned virologist Peter Piot, FDA’s Peter Marks and CEPI’s Richard Hatchett discussed multiple dimensions pertaining to coronavirus variants and existing vaccines at a recent conference, noting enhanced post-deployment surveillance is underway in the US. While there’s no need to panic for every variant that emerges, equitable access to vaccines is critical to ensure that gains made over last year are not undone, they said.
It’s yet another internal deadline missed by the US agency in publishing a draft of its overhauled Quality System Regulation, which is being harmonized with international quality systems standard ISO 13485.
US FDA’s Peter Marks notes timeframe for sponsors to seek licensure at press call announcing emergency use authorization of J&J’s vaccine; Acting Commissioner Woodcock says effectiveness comparisons cannot be made between the three authorized vaccines since they have not been tested head-to-head.