There is a new proposed piece of legislation that appears to give approved holders of ANDAs the right to unilaterally revise their labeling to provide new safety information that is not found in the labeling of the reference listed drugs (RLDs). Over the years, many proposals have been put forward to change the way that […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs. It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act […]
