The FDA’s effort to overhaul its generics division is finally taking shape. Regulatory Focus reports that the Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012, but problems, such as staff turnover, have slowed things down, just as the importance of generic drugs in the US has accelerated.
RF stumbled across a low-key FDA announcement dated Monday that highlights some pretty significant changes, including four new division offices—research and standards, bioequivalence, generic drug policy and regulatory operations—and three new leaders.
