Zdrowie i gospodarka · 20/05/2022

FDA Announces Draft Guidance to Mitigate Drug Shortages: Industry Stakeholders Required to Develop Risk Management Plans

The Food and Drug Administration (FDA) has released a draft guidance to help pharmaceutical manufacturers and other stakeholders develop and implement risk management plans to prevent drug shortages, following the amendment of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in March 2020.