an excerpt from WSJ: "Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, denies that the agency has become "more conservative" about drug safety. Rather, she says, the industry's faltering research efforts are mostly to blame for the fewer product approvals. She says the agency continues to base its decisions on science, not outside pressures. New methods, she adds, have helped it become more vigilant about side effects. She attributed the increase in black-box warnings primarily to a few large groups of medicines that were relabeled."
They don't clarify methods. But if its related to programmed prediction models on CYP inhibition/hepatotoxicity/HERG channel inhibition - the most common reasons for black box warnings/and non-approvals; we may be in a good place.