Priorities for a New FDA

I stumbled across this article almost by accident and it ended up sparking some interesting thoughts so I’m sharing it.

The FDA (U.S. Food and Drug Administration) is trialling a new approach where drug sponsors submit key paperwork before clinical trials are complete. The goal is to speed things up by reviewing manufacturing plans, labels, and packaging early. It made me wonder why this step usually comes after trials. The answer makes sense: regulators want to avoid wasting time on drugs that might not work. At first, I started weighing the benefits of doing all the paperwork upfront instead. But then I caught myself in a familiar trap, trying to replace one way with its opposite. The smarter thought/strategy is probabaly somewhere is the middle. And this is what the FDA are ultimately truing to do: review parts in parallel, saving time without compromising safety. So good luck to them!

I was relieved to see the focus on cutting genuinely unnecessary procedures, using AI for early reviews, and reducing animal testing. But then that got me thinking… who decides what counts as redundant? And could there be scenarios where something may seem unnecessary on paper might still matter in practice. Hard to imagine there wouldn’t be!

The section on healthier food for children also stuck with me. Why, in 2025, do we still not have a global standard for something as basic as baby formula? Surely that could be a shared recipe by now. Crazy.

https://jamanetwork.com/journals/jama/fullarticle/2835314