The Food and Drug Administration is extending the public comment period for its proposal to change the labeling rules for approved drugs and biological products.
In November, the administration proposed changing the labeling rules to allow generic drug manufacturers, who are abbreviated new drug application holders, to update their product labels to reflect certain types of newly acquired safety-related information even if the revised label differs from the label on the corresponding brand name drug.
FDA said revising its regulations would allow generic drug manufacturers to update labels the same way brand drug manufacturers can improve their communication of important, newly acquired drug safety information to health care professionals and the public without FDA approval prior to distribution.
The public now has until April 27 to comment on the rule. A public hearing will also be held on March 27 from 8 a.m. to 5 p.m. Attendees must register for the meeting by March 20.