Orrin Hatch said...

FDA's proposal to regulate LDTs is a significant change that would impose considerable new burdens on regulated parties.

One issue that significantly affects many entities in my home State is the FDA's October 2014 proposed guidance on the r...

If we don't allow enough data exclusivity time, we're not going to develop these therapies, especially in bio, because b...

If we reduce that data exclusivity time, especially with regard to bio, you're talking about having to charge a lot more...