FDA Applications during Covid-19: better Communication planned
Recommendation
10/11 February 2026
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
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The FDA has updated their Questions and Answers document "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency" (Guidance for Industry).
So far, industry wasn't happy with FDA's communication regarding concerns from remote document reviews. This is particularly important for the instances which could have been clarified or resolved easily as many remote reviews are ongoing and products awaiting approvals are in line.
The important and relevant paragraph from the revision now states: "FDA is also working directly with facilities to communicate any issues identified through a review of records or other information requested. For example, for both CDER- and CBER-regulated products, interim processes have been implemented to communicate with manufacturing facilities regarding issues identified following a review of records or other information requested in advance of or in lieu of a pre-approval or pre-license inspection. Responses from the facility regarding these issues will, as feasible, be considered before taking an action on a pending application." (see question 5).
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