FDA米国内査察再開

FDAが2/7から米国内査察を再開

RAPSの記事によると、FDAはCOVID-19の新規感染者数の減少を根拠に、 2022 年2月7日に国内監視検査業務を再開すると発表し
FDAのバージェス氏は、引き続きミッションクリティカルな国内および海外の検査を実施し、代替ツールとリモート評価を使用して「食品、医薬品、医薬品、タバコの効果的な監視を実施する。」と述べた。

昨年の12月29日、FDAは進化するCOVID-19のパンデミックおよびオミクロン株の変異とその蔓延にさらに適応するため、FDA職員と規制対象企業の安全を確保するために、査察の多くを一時的に停止すると発表した。当時、FDAは、「必要に応じて計画を再評価する」ものの、ミッションクリティカルな国内および海外の検査を除くすべてを1月19日まで停止するとした。
その後、2月4日まで査察の一時停止を延長したと報告していた

またバージェス氏は「当局はまた、国の認可を受け、米国疾病予防管理センター(CDC)のレベル1またはレベル2のCOVID-19渡航勧告の範囲内にある以前に計画された外国の査察を継続する。追加の外国査察の計画は進行中であり、4月から外国における優先順位の高い査察を実施すること予定している。」とも述べた。
現在、日本はCDCのレベル3であるため、4月以降も現状のままである場合は、ミッションクリティカルな製品を除き、FDA査察は実施されないことになる。

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