FDA Updates Standards for Biologics

The Food and Drug Administration is amending standards for general biological products to remove outdated and duplicative requirements, it said in a direct final rule (here). Among other changes, the agency is changing standards relating to dating periods and removing some provisions on standard preparations and limits of potency, it said. The direct final rule takes effect Sept. 16, 2016, unless FDA receives comments opposing the changes and withdraws the amendments. FDA also issued an identical proposed rule (here) it will consider if it withdraws the direct final rule.