FDA Coronavirus (COVID-19) Update: July 9, 2021

Angie Szumlinski News

  •  In September 2020, the FDA funded a study, conducted by America Makes, to summarize the impact of 3D printing on the overall COVID-19 response. The FDA has now made publicly available this report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows successes, challenges and key lessons learned to build on and improve future crisis response. 
  • The FDA issued an Emergency Use Authorization (EUA) to Ortho-Clinical Diagnostics, Inc., for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Test. The test measures IgG antibodies to SARS-CoV-2, the virus that causes COVID-19, from an individual’s blood sample (serum and plasma) to aid in identifying people with an adaptive immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. 
  • As part of the FDA’s effort to protect consumers, the agency issued warning letters to 12 firms for offering for sale in the U.S. adulterated and misbranded tests, face masks, respirators and surgical masks, some of which are intended for use in the mitigation, prevention, treatment, diagnosis or cure of COVID-19 in people.
  • The FDA hosted a Grand Rounds lecture about regulatory science research funded by the FDA: SARS-CoV-2 Host-Pathogen Interaction, Vaccines & Variants of Concern. This lecture discussed work from two FDA Medical Countermeasures Initiative (MCMi) projects analyzing coronavirus samples to help inform development of COVID-19 medical countermeasures, conducted by Public Health England and the University of Liverpool. A webcast recording is available. 

You can read the rest of the update on the FDA’s official website.