COVID-19: FDA Schedules 4 More Virtual Town Halls Through May
The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the coronavirus.
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Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.
The US FDA’s updated regulatory agenda says the agency will release a draft of its revised QSR in June 2021. But industry has seen this song and dance before – so will the FDA finally deliver the goods this time?
To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments
Three Becton Dickinson facilities have been approached by the US agency to take part in the voluntary virtual assessments; the medtech giant declined one and accepted two. BD’s VP of quality and regulatory compliance explains why.