The FDA has unveiled, after much hard work, several guidances on everything from companion diagnostics, to biomarkers, to what safety data has to be included in pre-clinical and Phase I research. That's on top of yet another proclamation about how the agency is focused on regulatory science (isn't that a contradiction in terms?) that will speed innovation. We heard and saw that from the FDA about three other times this year. And everything said or written is a footnote to the Critical Path report that was ignored after the Vioxx hysteria.
Guidances are okay but they are no substitute for less regulation and more scienced-based common sense, as evidenced by this account of how farmers may soon have to regulate...dust.
blog.heritage.org/2011/08/20/president-obamas-regulatory-dust-up/
Guidances are okay but they are no substitute for less regulation and more scienced-based common sense, as evidenced by this account of how farmers may soon have to regulate...dust.
blog.heritage.org/2011/08/20/president-obamas-regulatory-dust-up/
