The FDA is once again pushing back the release date for a final rule on safety information for generic drug labels, moving it from July to next spring.
A notice filed with the Office of Management and Budget shows the final rule is scheduled to be issued in April 2017, but an FDA spokeswoman informed Drug Daily Bulletin that this is simply a projected date and “may be adjusted to reflect ongoing work” on the rule. This is the third time that the agency delayed the rule since its proposal in 2013.
Once finalized, the rule will enable generic drugmakers to update their labeling to provide warnings about newly discovered risks to patient safety without prior FDA approval. Current regulations allow only NDA and BLA holders to make safety updates without agency approval.