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- CARES Act Reforms Aim to Prevent Shortages of Critical Medical Products
CARES Act Reforms Aim to Prevent Shortages of Critical Medical Products
April 5, 2020, Covington Alert
On March 27, 2020, Congress passed and the President signed into law H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). Recognizing the critical supply chain risks posed by the COVID-19 pandemic, Congress included multiple provisions in the CARES Act that aim to mitigate and prevent future medical product shortages (these provisions are primarily located in Part I of Title III, Subtitle A of the Act). These provisions include notable amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act), as summarized in this alert..
FDA Releases Guidance on Resuming Normal Drug and Biologics Manufacturing Operations During COVID-19
September 17, 2020, Covington Alert
Drug manufacturers have responded to the COVID-19 pandemic by adopting measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, some have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and mitigating ...
June 22, 2020, Covington Alert
Drug manufacturers have responded to the COVID-19 pandemic by adopting critical measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, they have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and ...
March 30, 2020, Covington Alert
On Friday, March 27, 2020, the U.S. Food and Drug Administration (FDA) released updated guidance to ensure that drug manufacturers notify FDA as soon as possible of potential interruptions in manufacturing that could lead to drug shortages. The Guidance, titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of ...