FDA Email Alert: Next Day’s Manufacturing Volume Reporting Due Date Still Voluntary
Executive Summary
Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement. Action reflects confusion that can arise in interpreting policy guidance.
You may also be interested in...
Greater US FDA And Manufacturer Transparency Recommended As Key to Supply Chain Resilience
Manufacturers could risk losing FDA product approvals if they fail to publicize sourcing and quality information, under new proposals. National Academies expert panel says supply chain transparency – not a pandemic-induced rush to onshoring requirements – provides the framework to mitigate against and respond to drug shortages.
Industry Balks At Deadline For New Manufacturing Volume Reporting Requirements
Comments cite requests for delayed or phased implementation, question how data will be used, and ask whether current reporting avenues could be used to gather similar information, among other concerns.
How US FDA Wants Pharmaceutical Production Volumes Reported For Drug Shortage Prevention
Monthly data are expected in annual reports on listed drugs and active ingredients from every registered site, starting in February.