- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, to help protect consumers from methanol poisoning, the FDA issued a new guidance, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs. Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects.
- To accelerate the adoption of advanced and smart manufacturing technologies to help strengthen the nation’s public health infrastructure, the FDA created a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MOU). This MOU is intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of pharmaceuticals, biopharmaceuticals and medical devices—including those necessary to fight the COVID-19 pandemic—through adoption of 21st century manufacturing technologies. These include smart technologies, such as artificial intelligence and machine learning, and emerging manufacturing processes. The MOU signals alignment between senior leadership at both institutions in recognition of the importance of modernizing regulatory frameworks as well as industry practices to meet public health needs in the U.S.
- The FDA updated its “Investigational COVID-19 Convalescent Plasma” guidance and corresponding webpage. The revisions provide recommendations regarding when individuals who have received an investigational COVID-19 vaccine as a participant in a clinical trial, or received an authorized or licensed COVID-19 vaccine, qualify as convalescent plasma donors. In addition, the agency has extended the period of enforcement discretion described in the guidance.
- The FDA also posted updated information on its website for blood establishments regarding the COVID-19 pandemic and blood donation.
- Testing updates:
- As of today, 319 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 237 molecular tests and sample collection devices, 69 antibody tests, and 13 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Abby Capobianco