Elise Paeffgen on Emergency Use Authorization (EUA)

FTC to Probe Supply Chain Issues of Major Companies – Medical Products Supply Chain Week in Review

In the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on their supply chain issues and solutions. The FDA issued an emergency use authorization (EUA) for a...more

12/20/2021 / Emergency Use Authorization (EUA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Medical Supplies , Office of Foreign Assets Control (OFAC) , Supply Chain , Vaccinations

Medical Products Supply Chain Week in Review – October 2021 #2

Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA also proposed a new rule for over-the-counter (OTC) hearing aids. The...more

10/25/2021 / Biden Administration , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Supplies , Supply Chain

Medical Products Supply Chain Week in Review – October 2021 #1

Last week, AstraZeneca and Merck filed emergency use authorization (EUA) requests for their COVID-19 drugs. The FDA provided information to the public about a database repository of gene variants and associated conditions....more

10/15/2021 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Supplies , Pharmaceutical Industry , Supply Chain , Vaccinations

Medical Products Supply Chain Week in Review – September 2021 #3

Last week, the White House COVID-19 Response Team indicated the Administration is ready to begin providing booster vaccine doses to eligible Americans. The FDA alerted clinical laboratory staff and health care professionals...more

9/30/2021 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Supplies , Supply Chain , Vaccinations

Medical Products Supply Chain Week in Review – September 2021 #2

Last week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met and provided recommendations on the COVID-19 booster dose, and yesterday the FDA authorized the booster dose for certain...more

9/24/2021 / Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Supplies , Supply Chain , Vaccinations

Medical Products Supply Chain Week in Review – September 2021 #1

Over the last two weeks, the President signed Executive Orders requiring all federal employees and contractors to be vaccinated. The White House COVID-19 Response Team announced a $3 billion investment in the vaccine supply...more

9/15/2021 / Biden Administration , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Supplies , Supply Chain , Vaccinations

Medical Products Supply Chain Week in Review – August 2021 #3

Last week, the FDA amended the Moderna and Pfizer-BioNTech emergency use authorizations (EUAs) to allow an additional dose of the mRNA COVID-19 vaccine for immunocompromised individuals. In addition, the Secretaries of...more

8/19/2021 / Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Supply Chain , Vaccinations

COVID-19 Medical Products Supply Chain Week in Review – July 2021 #1

Last week, the White House released a framework for U.S. leadership in the global COVID-19 response. In addition, the FDA is revoking the emergency use authorizations (EUAs) of all non-NIOSH-approved disposable respirators...more

7/7/2021 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Vaccinations

COVID-19 Medical Products Supply Chain Week in Review – June 2021 #5

Last week, the FDA added new heart health risk information to mRNA vaccines’ fact sheets. In addition, the U.S. seized unauthorized COVID-19 drugs en route from Bangladesh and India to Mexico. ...more

6/29/2021 / Biden Administration , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Manufacturers , Medical Supplies , Popular , Supply Chain , Vaccinations

Elise Paeffgen

Alston & Bird

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