Food and Drug Administration; Center of Drug Evaluation and Research Guidance Documents Related to Coronavirus Disease 2019, Expiration

概要

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of guidances for industry entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act," which posted March 2020 to communicate recommendations for notifying the Agency about the permanent discontinuance or interruption in manufacturing of certain drug products; and "COVID-19: Potency Assay Consideration for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity" which posted January 2021 to communicate information on the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. FDA is withdrawing these two guidance documents because new draft guidances are available that reflect comments received on the COVID-19 guidances, and many of the recommendations set forth in the COVID-19 guidances are applicable outside the context of the public health emergency (PHE) and included in the draft guidances.