Remote FDA drug inspections: New draft guidance spells out post-pandemic specifics

One of the FDA’s biggest tools from the pan­dem­ic is here to stay, and the agency re­leased new draft guid­ance on how it plans to re­quest and con­duct vol­un­tary re­mote in­spec­tions of fa­cil­i­ties where drugs are man­u­fac­tured, packed, com­pound­ed or held.

The 10-page draft re­leased Wednes­day, which re­places a sim­i­lar draft from April 2021, ex­plains which re­mote in­ter­ac­tive tools the FDA may use to re­quest an in­spec­tion, in­clud­ing but not lim­it­ed to in­spec­tions oc­cur­ring pri­or to a new drug ap­proval, parts of sur­veil­lance drug qual­i­ty in­spec­tions ex­am­in­ing over­all op­er­a­tions, and fol­low-up or com­pli­ance-re­lat­ed in­spec­tions.

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