Not later than 1 year after December 29, 2022, the Secretary shall establish an intra-agency coordinating council (referred to in this subsection as the “Council”) within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 356(c) of this title.
The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval.