FDA: actions related to COVID-19

• FDA added hydroxyclhloroquine sulfate to category I under the interim policy on compounding bulk substances. Documents available at: https://www.fda.gov/media/94164/download

https://www.fda.gov/media/94402/download

• FDA published instructions to facilitate the entry of needed products including personal protective equipment. Information on products that can be imported into the USA wihout engaging the FDA has been provided to importers and manufacturers. Documents are available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-increase-us-supplies-through-instructions-ppe-and

• The Emergency Use Authorizations by the FDA for diagnostic tests are available at : https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization