FDA Extends Comment Period on Proposed Generic Drug Labeling Changes

The Food and Drug Administration is extending the deadline for comments on its proposal to liberalize requirements for labeling changes on generic drug and biological products. The Nov. 13 proposed rule would allow generic drug and biological product manufacturers to update safety labels without preapproval from FDA, which would give generic drug companies the same flexibility as their brand-name counterparts (see 13111213). FDA is also amending its proposal to add references to its analysis of the change’s impact. Comments on the proposed rule are now due by March 13, and comments on information collection issues related to the proposed rule are due by Feb. 11.