Business · 04/05/2016Updated: 10/17/2026 · 1 min read

Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule

The Food and Drug Administration (FDA) is proposing to update its biological products standards by removing outdated requirements and accommodating new technology and testing capabilities, while maintaining public health protections. This proposed action is part of the FDA's retrospective review of its regulations in response to an Executive order.