Another step towards a fully digital future, straight from the FDA’s oven.
FDA has published for comments another breakdown of the CTD into (what could be) machine-readable “atoms”, whereby each element in the CMC portfolio is codified and embedded into a specific bucket.
We went a long way from the horror stories of trucks full of paper submissions, but there is still a long way to go- because making sense of thousands of pages in a typical regulatory submission still takes a long time and a village of people, in spite of the electronic format and CTD standardization.
Even if all this sounds like a faraway future for your project, here is my take: Start now.
As we can all see- the future is coming faster than anticipated, and the sight of a regulatory authority being the front-runner in the digital transformation of the industry is inspiring.
Let’s take on their lead and start feeding our data into a structured system. Because one day, not far from now, this will be the regulatory standard.
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