FDA査察中断

FDA査察の中断について

米国連邦政府が一部閉鎖され業務が停止されている。
それに伴い、FDA査察が一部中断されている模様だ。
FDAスタッフ全体(17,397人)中、41%(7,053人)がfurlough(一時解雇)状態である。

しかしながら、FDAの査察官は約400人が無給で査察を継続しているという。
そのうちの約100人が医療機器担当だ。
FDA長官は、彼らボランティアに対して謝辞を繰り返し述べている。

本件についてFDA長官がツィートした。
政府閉鎖中も、医薬品、医療機器、食品について国内外のハイリスク製品や施設に関しては定期査察も実施するとのことだ。

CBSニュースによると食品は米国内の定期査察は停止しているが、国外査察は継続中とのことである。

CBS

ヒト用の医薬品を管轄しているCDERも一部活動を継続しているようだ。

一方で、医療機器を管轄するCDRHは、ほとんど活動していないように思われる。
最近、ホームページの更新がわずかにあったが、メール等の配信等全くない状況である。
現在、米国政府は予算を凍結しているが、CDRHはUser fee(申請者等から徴収した費用など)によるfundが2~3か月分あるという。
これが尽きるまでは一部業務は継続される模様だ。
ただし、犯罪捜査、公衆衛生への危害を防ぐために重要な任務を担っている職員が優先されている。

レギュレーション作成を担うスタッフ、CFSAN(食品)のスタッフのうち輸入インスペクションやリコール等、公衆衛生にかかわらないスタッフなどはfurlough状態だ。
このため、ガイダンス等の発出が滞っている。

なお、furloughまたは無給で働く職員への補償に関する予算が法制化されている。

【お知らせ】
イーコンプライアンスではFDA査察対応セミナーをオンラインで配信しています。(有料)
詳しくはこちらをご参照ください。

https://www.youtube.com/watch?v=zIHXobIP_vo


関連VOD配信セミナー
当社VOD配信セミナーは、視聴期間および回数制限はございません。
お好きな時間に、繰り返し何度でもご視聴いただけます。
FDA査察対応セミナー
セミナービデオはこちら

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