In a prior publication PAHO has stressed the moral obligation to do research about COVID-19 as quickly as possible to produce the evidence that is needed to respond to the pandemic.

This new publication provides guidance and strategies to streamline the ethics review and oversight of COVID-19-related research with human subjects. It is available at: https://www.paho.org/en/documents/guidance-and-strategies-streamline-ethics-review-and-oversight-covid-19-related-research.

In an upcoming publication a template of standard operating procedures for ethics review in emergency situation, which committees can adapt to their contexts and adopt will be given.

The National Regulatory Agency in Chile (Instituto de Salud Pública, ISP) has made available online the COVID-19 action plan, that inlcudes the updated list of IVDs, pharmacovigilance, health alerts besides news and information on COVID-19.

Additional information:

• http://www.ispch.cl/covid-19
• ISP informs about regulation of products for clinical trials

The latest information on FDA actions related to COVID-19 are available at: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19#new

At-a-glance: FDA COVID-19 response summary

Medical Devices:

FDA posted a new webpage with frequent questions and answers on importing medical devices during the COVID-19 pandemic

Drug Shortages: FDA updates its webpage on COVID-19 drug shortages responses 

Hand Sanitizers containing methanol: List of recalled hand-sanitizers that contain undeclared methanol as ingredient

Emergency Use Authorizations (EUA):

• FDA authorizes first COVID-19 Test for Self-Testing at Home (NEW)
• FDA revokes EUA for Chloroquine and Hydroxychloroquine
• FDA is reissuing certain EUA to specify which respirators are appropriate for decontamination
  • Respirator models no longer authorized 
  • FDA issues EUA to Decontaminate N95 Respirators
• FDA reissued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria 
• FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesevir
  • Warning about a newly discovered potential drug interaction related to the remdesivir
  • Frequently Asked Questions on the EUA for remdesivir
• FDA regularly updates the Emergency Use Authorizations (EUA) for diagnostic tests.

Product-Specific Guidance:

• Chloroquine Phosphate and Hydroxychloroquine Sulfate
• FDA reiterates risks of antimalarial drug use for COVID-19

Abbreviated New Drug Applications (ANDA): Albuterol sulfate inhalation solution 0.021% and 0.042%

Guidelines:

• Exemption and exclusion from certain requirements of the drug supply chain security act during the COVID-19 public health emergency

Serology tests for COVID-19 : The FDA issued an  note about the importance of serology tests for  COVID-19 as well as the situation about firms falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19

Reference links for fraudulent COVID-19 products:

• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-combat-fraudulent-covid-19-medical-products
• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits
• https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
• https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
• https://www.cbp.gov/newsroom/local-media-release/cbp-officers-o-hare-seize-prohibited-medical-test-kits
• https://www.flickr.com/photos/fdaphotos/albums/72157713334402986
• https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products

R&D: https://www.fda.gov/medical-devices/database-reference-grade-microbial-sequences-fda-argos/fda-argos-sars-cov-2-reference-grade-sequence-data

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Coronavirus Treatment Acceleration Program (CTAC)

Adverse Event Reporting for Medical Devices under EUA or discussed in COVID-19 related guidance document.

Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)

FDA encourages recovered patients to donate plasma for development of blood-related therapies

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The Center for Drug Evaluation and Research (CDER) launch a webpage with activities and information related to COVID-19: https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs

• 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

We invite you to participate in this virtual seminar to present and discuss PAHO’s ethics guidance for COVID-19 research available at: https://www.paho.org/en/documents/ethics-guidance-issues-raised-novel-coronavirus-disease-covid-19-pandemic.

To participate follow this link: https://paho.webex.com/paho/onstage/g.php?MTID=eb1e5b00997fab7e37c834c5d35d9ad3f

Tuesday March 31 2:00 – 3:30 pm, Washington D.C. time (In English)

We are waiting for you.

PANDRH Secretariat

Go to this Safety Alert at MedWatch