NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL. Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at the end the following: “The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 505–1(g)(2)(D).”.121 STAT. 944