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

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

Regulatory Impact Analysis

The Food and Drug Administration is proposing to amend the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements.  FDA is proposing this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without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:83 FR 3631, January 26, 2018

Docket: FDA-2017-N-7007