Many of us have been there; you have some initial stability data that would save a lot of time and money if you didn’t have to support it with further studies, but sometimes circumstances cast regulatory shadows that bring about difficult decisions. What to do?
Wow, common scenario for organizations watching their resources and tight on time. Short cuts can quickly draw fire from regulatory authorities, so starting a focus there may be the best strategy. Communicate with them (through your internal Regulatory) to demonstrate the significance of your product to the healthcare community and lay out a plan to prove stability along the way with solid justifications. You may need to be quite creative, but these days, “quite creative” solutions seem to be gaining a foothold. You might even explore some accelerated avenues such as an Isoconversion program.
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