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Chinese Manufacturers of Personal Protective Equipment Gave False U.S. Agent Information to Food and Drug Administration

U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more

FDA Revokes Emergency Use Authorization For Highly Watched Chloroquine and Hydroxychloroquine - But They Can Still Be Prescribed

FDA recently revoked a multi-month Emergency Use Authorization (the EUA) for use of chloroquine and hydroxychloroquine as an experimental treatment for patients suffering from COVID-19. ...more

FDA Updates Emergency Use Authorization For Chinese Respirators

Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more

CDC Provides Recommendations for Respirators When N95 Respirators Are Not Available in COVID-19 Crisis

To combat shortages of N95 respirators, the Centers for Disease Control and Prevention issued and continues to update its Strategies for Optimizing the Supply of N95 Respirators. The CDC’s N95 Respirator Strategies provide...more

FDA Emergency Use Authorizations (“EUA”) for COVID-19: What is an EUA and What is Currently Covered?

Starting in February 2020, the US Food and Drug Administration (the “FDA”) began using its Emergency Use Authorization (“EUA”) powers under Section 564 of the Federal Food, Drug, and Cosmetic Act (“FD&C”) to allow unapproved...more

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