Withdrawal of Notice Regarding the Food and Drug Administration Drug Review Timeline Transparency; Revocation of Statement of Policy

Resumo

The Department of Health and Human Services (Department or HHS) and the Food and Drug Administration (FDA or Agency) are issuing this notice to withdraw the notice published in the Federal Register of January 15, 2021, announcing a Statement of Policy indicating that FDA will publish certain information regarding the timeline for its review of drug product applications. The Department and FDA are withdrawing the notice and revoking the Statement of Policy because, among other things, the notice did not account for all relevant considerations related to information that is already publicly available about FDA's review of drug applications.