In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more
2/1/2022
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Centers for Disease Control and Prevention (CDC) ,
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Vaccinations
Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more
Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more
In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in...more
In the past week, the FDA authorized the Pfizer and Moderna booster shots for all adult age groups, while the CDC Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster for all...more
In the past week, the President has selected Dr. Robert Califf to be FDA commissioner. Congress passed the Infrastructure Investment and Jobs Act. New vaccination requirements were issued by OSHA and CMS for certain...more
In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a...more
Last week, the White House COVID-19 Response Team encouraged school systems to implement a layered approach to prevention as schools return to in-person learning. Moderna submitted a Biologics License Application (BLA) for...more
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
Last week, the Administration’s COVID-19 Response Team reported that the case numbers continue to rise in low-vaccination states, with most infections as a result of the Delta variant. Vaccination rates, however, are starting...more
Last week, six U.S. agencies updated an advisory to urge businesses to conduct human rights due diligence for supply chain links to Xinjiang, China. In addition, the Pfizer/BioNTech COVID-19 vaccine received Priority Review...more
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
Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s first guidance on remote interactive evaluations, a tool in response to the agency’s COVID-19 inspection postponements....more