Updates on the CARES Act
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This session also will provide an update on the CARES Act, particularly the status of the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Sections 510(j)(3) of the FD&C Act and share learnings from the reports for the calendar years 2020, 2021 and 2022. In addition, this session will provide an update on FDA’s implementation plan and expectations of the draft guidances: Risk Management Plans to Mitigate the Potential for Drug Shortages and Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.
