All industries are regulated to one degree or another. When putting chemicals, biological molecules, or even living cells into humans, regulatory hurdles get very high indeed. To a great degree, regulatory issues define drug developers’ strategies, paths to liquidity and market, and ultimate success. Regulatory decisions frequently buoy or tank stocks, moving billions of dollars in investment capital, and far more importantly, evaluating which medicines have sufficiently attractive benefit/risk ratios. As such, regulatory bodies must be rigorous, expert, and entirely objective. The US Food and Drug Administration is the world’s leading regulatory body, and is highly functional and professional.