FDA Amends Biologics Regulations to Remove Outdated Requirements and Introduce Risk-Based Inspection Frequency

Summary

The Food and Drug Administration (FDA) is issuing a final rule to amend the general biologics regulations, removing outdated requirements and introducing a risk-based inspection frequency for drug and device establishments, aiming to provide flexibility without compromising public health protections. This action is part of FDA's efforts to review and update existing regulations as mandated by Executive Orders 13771 and 13777.