As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with…
— Read on www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market
This is worth reading. I remember when I first started it was easier to get European approvals before US, and have been surprised by the switch over the last few years.
I also watch all these companies struggle with QbD and wonder if these two trends go hand in hand.
No answers from me, but I do recommend reading this article.