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  1. Economic Impact Analyses of FDA Regulations

Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products (Final Rule) Regulatory Impact Analysis

The Food and Drug Administration is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements.  This action is being taken to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device establishments, thereby providing flexibility without diminishing public health protections.  Because this rulemaking would remove regulations to be consistent with updated practice and does not impose any additional regulatory burdens, this rulemaking is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

Federal Register: 84 FR 12505, April 2, 2019

Docket: FDA-2017-N-7007