Why does FDA think the Critical Path infrastructure needs to be modernized?
Despite important investments in basic biomedical research, the number of applications to the FDA for new drugs and biologics has declined over the past decade. Of more concern, product development is not becoming more efficient over time – a drug entering Phase 1 trials in 2000 was not more likely to reach the market than one entering Phase 1 trials in 1985. And we are seeing more product candidate failures in the later stages of product development — the most expensive way to fail. Recent biomedical research breakthroughs have not improved the ability to identify successful candidates and bring the most promising products to patients in a timely and affordable manner. We can see a wide range of opportunities to improve the efficiency of product development. But without a concerted focus on the applied science necessary to develop these new approaches, the inefficiencies and unnecessary costs of product development will continue to escalate.
