FDA Undertakes News Action in Its Ongoing Response to Covid-19 Pandemic
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic
The FDA held a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the Emergency Use Authorization (EUA) request from Janssen Biotech Inc. for its COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Meeting materials are available on the FDA’s webpage.
The FDA added new devices to the device discontinuance list, including sterilization products and oxygen conservers. There are no updates to the device shortage list at this time. The FDA will continue to update the device discontinuance and device shortage lists as the COVID-19 public health emergency evolves.
The FDA’s Office of Medical Policy within the Center for Drug Evaluation and Research presented about the role of the CURE Drug Repurposing Collaboratory (CRDC) in drug repurposing for neglected tropical diseases as well as COVID-19 at an International Society of Neglected Tropical Diseases online conference on February 24. The CRDC is a public-private partnership among C-Path, FDA and the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health. The CDRC is designed to capture real-world clinical outcome data to advance drug repurposing and inform future clinical trials for diseases of high unmet medical need.
The FDA continues to warn consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested. The agency has discovered that some hand sanitizers are being packaged in beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles. Manufacturers should be vigilant about avoiding packaging and marketing their hand sanitizers in containers resembling food or drink packages in an effort to mitigate any potential inadvertent use by consumers.
The agency added some of these products to the do not use list of hand sanitizers and urges consumers to be cautious of hand sanitizer packaging. Hand sanitizer can be toxic when ingested. Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer. The FDA continues to monitor these products and will take appropriate actions as needed to protect the health of Americans.
