Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, May 4, 2020
Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy
As we at the FDA have said before, every step we have taken in our approach to COVID-19 testing has been a careful balancing of risks and benefits – all done to anticipate and meet continuing and evolving public health needs as we combat this virus. That’s why today the FDA issued an update to a policy from March 16, 2020 on antibody tests for COVID-19.
High-quality antibody tests (a type of serological test) can help us understand a person’s and population’s exposure to COVID-19. A person who has been exposed to, and recovered from, COVID-19 will likely have antibodies to the SARS-CoV-2 virus in their blood. These tests may be important for guiding our next steps in the fight against this pandemic, such as by providing information on disease prevalence and the frequency of asymptomatic infection, and also by identifying potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe or immediately life-threatening disease.