4 August 2017 - The FDA won’t be issuing a controversial final rule on label changes concerning generic drug safety any time soon.

Under the rule, generic drug manufacturers would be able to independently update product labelling with newly acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do. 

Generic manufacturers also would be required to inform the brand name manufacturer about the change under the rule, which was proposed in 2013.

Read Bloomberg article