US: FDA plans to resume on-site domestic inspections as of 20 July 2020
The Food and Drug Administration (FDA) announced the plan to resume on-site domestic inspections beginning the week of 20 July 2020.
The resume process will be different in each state according to local rules and epidemiological situation. Moreovoer, a new risk assessment system will be put in place to measure the risk in each and every state and determine what types of regulatory activities the agency and its partners carry out at the country level.
For more details, please see the press release from the FDA.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
