Regulation Needs Some Heft

Regulatory science needs to be improved and given more strength, says Margaret Hamburg, the new FDA director. Blogger Michael Christel at R&D Direction Insider covered Hamburg's keynote address to the Regulatory Affairs Professionals Society meeting and he writes that any changes "must be fully embraced in academic, industry, and government circles." Hamburg added, "We cannot afford to have a muscular investment in fundamental research and discovery but only a scrawny counterpart in regulatory capacity. Our efforts will be seriously compromised if we don't convincingly increase the sophistication of our regulatory science soon."