More than a year after issuing Emergency Use Authorizations (“EUAs”) for filtering facepiece respirators (“FFRs”), surgical masks, and related personal protective equipment (“PPE”), the Food and Drug Administration (“FDA”) is walking back these measures. On June 30, 2021 the FDA announced the revocation of the EUAs for all imported, disposable FFRs not approved by the … Continue Reading
Background On January 31, 2020, the Secretary of the Department of Health and Human Services (“HHS”), Alex M. Azar II, declared a public health emergency due to a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes novel coronavirus disease 2019 (“COVID-19”). In the weeks following the declaration of the public … Continue Reading
On June 27, 2012, the U.S. Senate passed (by a vote of 92-4) the Food and Drug Administration Safety and Innovation Act, a bill primarily designed to let the U.S. Food and Drug Administration (“FDA” or “Agency”) collect user fees from prescription drug and medical device manufacturers to help fund the Agency. The House of … Continue Reading
