US FDA & MAPP Propose New Rules for Generic Drug Labeling
Recently, Per the revised Manual of Policies and Procedures (MAPP) of the United States Food and Drug Administration (USFDA) has proposed new labeling rules under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (FD & C Act). This Section covers the FDA’s approval of an Abbreviated New Drug application (ANDA) even after a few changes in the labeling for the Reference Listed Drug (RLD). When the FDA’s approvals of labeling changes for the RLD and the ANDA are scheduled simultaneously, the revised process needs to be followed.