FDA’s inflection point

Having spent a year at FDA, former Chief Counsel Rebecca Wood sees the agency at an inflection point; it must make dramatic changes in the ways it applies and interprets the law under which it operates to keep up with advances in science and technology that weren’t even imagined when the law was crafted.

From July 2017 to July 2018, Wood played a leading role in crafting and facilitating policy changes at the agency. She helped shape initiatives to rethink the regulation of products in rapidly advancing fields such as regenerative medicine, digital health and diagnostics (see “Stepping Through”). ...