As a result of stakeholder requests, the U.S. FDA has extended the comment period for the public workshop titled “Evolving Role of Artificial Intelligence in Radiological Imaging” to June 30. The agency also has taken several actions this week in its fight against COVID-19. For one, the agency is allowing compounding pharmacies to use hydroxychloroquine to compound human drugs. In moving hydroxychloroquine to category 1 under its interim policy on bulk drug substances that can be used in compounding, the agency said it prioritized the substance due to the coronavirus emergency. Chloroquine phosphate was already a category 1 substance. The agency also issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories. Manufacturers may submit a request to the FDA to have their devices added to the EUA. In addition, the agency announced that as of Thursday, it has issued 16 EUAs for COVID-19 tests that can be used nationwide. The FDA said it has worked with more than 190 test developers who have indicated they will be submitting applications to make tests to detect the virus.
With the ongoing COVID-19 crisis, the U.S. Department of Health and Human Services (HHS) has issued a notice under Executive Order 13910 and section 102 of the Defense Production Act of 1950, designating health and medical resources necessary to respond to the spread of the pandemic that are scarce or the supply of would be threatened by excessive accumulation. The notice was issued March 25 and took effect the same day. The HHS secretary may designate certain resources as scarce materials or materials the supply of which would be threatened by hoarding. The notice has an impact on the following: