Compliance Corner: Follow These 11 Steps To Prep For FDA Regulatory Meetings
Longtime industry expert Steve Niedelman of the law firm King & Spalding offers manufacturers pointers so they’re not caught flatfooted during regulatory meetings with the US agency.
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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.
If the US FDA knew Steril Milano S.R.L. was falsifying ethylene oxide (EtO) certificates on 24 May, why did nine days pass before the agency alerted all of industry? The FDA explains the choice to Medtech Insight.