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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..
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 ...
July 2020
Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are ...