Footnote in court hints at new FDA rules for generic warnings

02/11/2013 | Pharmalot.com

The FDA may revise regulations so that makers of generic drugs can update labels to warn patients about risks, Ed Silverman writes. The Justice Department filed a friend-of-court brief in a case concerning generic drugs, and it carried this footnote: "This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances."

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