A 505(b)(2) NDA has the same approval requirements as a 505(b)(1) NDA, the only difference is where the pivotal data comes from . 505(b)(2) is not a shortcut in the sense that you can get by with less information. Clients are often amazed (the polite word) when they learn about the studies need to get their 505(b)(2)drug approved. The most frequent comment goes like this: ‘Ken, but…… the RLD only had to do (X, Y & Z studies) and you’re telling me that we have to do more studies, even though they are on the market?’Yes, time marches on and FDA, along with science, has learned a lot about what we know and what we don’t know. Hence, FDA is now mandated by Congress to demand more tests than even just 5 years ago. For instance, PREA is adding pediatric requirements that didn’t exist until last year. The list is getting longer.
It is even more important to dig into the body of public literature to avoid doing required tests that have already been done. We found data that a client’s “exhaustive” search didn’t uncover – saving them hundreds of thousands of dollars and months of time. Interestingly, another client said she thought FDA would have suggested the source of public data. As if the FDA would know…..