The US FDA has officially withdrawn its proposed rule that would allow generic drug sponsors to independently update their product labels with certain types of newly acquired information, and the agency may now turn to Congress for additional resources and authorities to help update labels more efficiently.
The rule had become a subject of controversy since it was first proposed in 2013, and FDA indicated in late 2017 that it would be formally withdrawing the rule. (Also see "FDA Proposes Unilateral Generic Drug Label Changes, Signaling End To Liability Shield" - Pink Sheet, 9 November, 2013