FDA Extends Comment Period On Generic Drugs Rule

Law360, New York (December 20, 2013, 2:19 PM EST) -- The U.S. Food and Drug Administration said Wednesday it will give drugmakers and others an additional two months to comment on its closely watched proposal to allow generic-drug manufacturers to independently update warning labels.

The agency is now accepting public input on the proposed rule through March 13, in response to requests for more time from stakeholders. The deadline for the Nov. 8 proposal originally was Jan. 13.

The proposed change would eliminate prohibitions preventing generics makers from revising safety information until the brand-name counterpart has...
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