• General actions:

The Brazilian National Regulatory Authority, Anvisa, is carrying out several regulatory and informative actions to address the international public health emergency related to SARS-CoV-2 (a new type of coronavirus), which causes COVID-19. All related information is gathered on the link: http://portal.anvisa.gov.br/coronavirus

Report on ANVISA’s actions to fight the pandemic  (NEW)

• IVD for COVID-19

The COVID-19 IVD  list is daily updated and is available here 

• Regulations and guidance:

The list of specific regulations and guidance is regularly updated and available at http://portal.anvisa.gov.br/coronavirus/regulamentos

• The FDA has made available in its webpage the Fraudulent Coronavirus Disease 2019 (COVID-19) Products
• The FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile to be distributed and used for certain hospitalized patients with COVID-19
• FDA expedites review of diagnostic tests to combat COVID-19
• FDA update on EUA for diagnostic tests
• 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic

The United States Pharmacopeia (USP) has made available some resources and information related to COVID-19 to the public:

• Free Access to USP-NF Standards Critical to the Development of Vaccines and Antivirals
• Free Technical Assistance for Developers of COVID-19 Antiviral Drugs and Vaccines
• Compounding Alcohol-Based Hand Sanitizer During COVID-19 Pandemic
• USP Response to Shortages of Garb and PPE for Sterile Compounding During COVID-19 Pandemic
• USP Reference Standards Supply Chain Information
• All On-Demand Education at a 75% Discount Through May 31, 2020: use the promotion code USPEDU75OFF upon check-out to receive discount

• 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

PAHO’s Regional Program on Bioethics has developed a document that provides ethics guidance for the public health response, health care delivery and research during current COVID-19 pandemic.

Such document is available at: https://www.paho.org/en/documents/ethics-guidance-issues-raised-novel-coronavirus-disease-covid-19-pandemic.

In the virtual seminar to PAHO’s ethics guidance for COVID-19 research was presented the imperatives to conduct rapid ethics review of COVID-19 research protocols and to promote future research through the use of broad consent were discussed.  The recording is available at: https://paho.webex.com/recordingservice/sites/paho/recording/718eb53feb6b4ba1abe8529be1b96586

Investigational COVID-19 Convalescent Plasma – Emergency INDs

FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization. This does not include the use of COVID-19 convalescent plasma for the prevention of infection.

Click here to access the complete information.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-laboratories-issues-voluntary-nationwide-recall-phytonadione-injectable-emulsion-usp-10