Geschäft · 19.10.20231 Min. Lesezeit
Food and Drug Administration; Center of Drug Evaluation and Research Guidance Documents Related to Coronavirus Disease 2019, Expiration
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
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.