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PAHO: Template and operational guidance for the ethics review and oversight of COVID-19-related research

New PAHO publication:

This document provides a template of standard operating procedures for ethics review in emergency situation, along with guidance for committees to adapt them to their contexts and adopt them. It is available at: https://www.paho.org/en/documents/template-and-operational-guidance-ethics-review-and-oversight-covid-19-related-research.

This publication supplements PAHO’s 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.

Both publications will be presented at a virtual seminar in English on Tuesday April the 21st at noon (Washington D.C. time). To participate go to: https://paho.webex.com/paho/onstage/g.php?MTID=eede4995e137569b2aa66bbb1d4ffccd9.

 
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INVIMA: actions related to COVID-19

The website with updated information on INVIMA’s action on COVID-19 as well as supply of medicines and medical devices in Colombia is available at  https://www.invima.gov.co/coronavirus-covid-19

Actions [Spanish]: 

Health Alert [in Spanish]:

The safety reports and health alerts issued by INVIMA are available through the following link: https://app.invima.gov.co/alertas/alertas-sanitarias-general

Resolutions [in Spanish]:

 
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FDA Guidance on conduct of clinical trials of medical products during COVID-19

 

This guidance aims to provide general consideration to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during COVID-19 pandemic.

The document is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

 
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PAHO – Virtual seminar: Strategies and operational guidelines  for the ethics review and oversight of COVID-19-related research

Virtual seminar:

Strategies and operational guidelines  for the ethics review and oversight of COVID-19-related research

In a publication available at:https://www.paho.org/en/documents/guidance-and-strategies-streamline-ethics-review-and-oversight-covid-19-related-research we provide guidance and strategies to streamline the ethics review and oversight of COVID-19-related research with human subjects.

We invite you to participate in a virtual seminar to discuss this publication and an upcoming one with a template of standard operating procedures for ethics review in emergency situations. In preparation for the seminar, we invite you to send your questions about these topics to bioethics@paho.org.

The virtual seminar in English will take place on Tuesday April the 21st at noon (Washington D.C. time). To participate go to: https://paho.webex.com/paho/onstage/g.php?MTID=eede4995e137569b2aa66bbb1d4ffccd9.

 
Categories

ANMAT: actions on COVID-19

In its web page, the National Regulatory Authority of Argentina (ANMAT) keeps information, recommendations of the Ministry of Health and actions on COVID-19 prevention:  https://www.argentina.gob.ar/salud/coronavirus-COVID-19

Further information is available in its original language (Spanish):

Enlaces de interés

Lista actualizada de los reactivos de uso in vitro para detección de COVID-19 

Plan Estratégico para regular el uso de plasma de pacientes recuperados de COVID-19 con fines terapéuticos 

Mecanismo simplificado para empresas que importen o fabriquen productos médicos críticos relacionados a la pandemia por COVID-19,

Mecanismo de emergencia para el registro de productos médicos críticos de clase I y II relacionados a la pandemia por COVID-19.

Aplicación de autoevaluación de síntomas de COVID-19 está disponible para que el usuário descargue la aplicación en su mobile

Estudios de farmacología clínica

Medidas y recomendaciones con el objeto de preservar las actividades de los estudios de farmacología clínica (EFC) protegiendo la seguridad y bienestar de los participantes del estudio.

Información específica:

Información Normativa:

 
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Health Canada: action on COVID-19

Fraudulent N95:

Health Canada warns about the  risks of using fraudulent and unauthorized N95 respirators, as they may not protect consumers against COVID-19:.https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72707a-eng.php

Likewise, the actions on COVID-19 from Health Canada are available at: https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19.html

 
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FDA: Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate

In anticipation of increased demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available by publishing product-specific guidances (PSGs) to support generic drug development for these drugs.

Additional information: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidances-chloroquine-phosphate-and-hydroxychloroquine-sulfate

 
Categories

FDA issues EUA to Decontaminate N95 Respirators

The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

Additional information: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-second-emergency-use-authorization-decontaminate-n95

 

 
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PAHO warns of potential blood shortages during the COVID-19 pandemic

News and Public Information

News release

 

PAHO warns of potential blood shortages during the COVID-19 pandemic

Countries in the Americas should ensure continuity of donations and safety for donors

Washington, DC, April 10 2020 (PAHO/WHO) – The Pan American Health Organization (PAHO) today warned that countries in the Americas face potential shortages of blood for transfusions due to a significant reduction in voluntary blood donations during this time of the COVID-19 pandemic.

According to the latest available data, in 2017 more than 10.5 million units of blood were collected, through 1,800 blood donation centers in 37 countries and territories of the Americas. Given the current pandemic, health services are now running the risk of shortages in availability.

“We are concerned that blood bank reserves are being depleted, as this puts at risk the lives of many people who need transfusions,” said PAHO Director Carissa F. Etienne. People with cancer and leukemia, people needing transplant services, and women who suffer postpartum hemorrhage are among those who arrive at hospitals every day requiring transfusions. In addition, emergency services require continuous availability of blood to respond to trauma cases arising from road traffic accidents and other injuries..

Dr. Etienne called on governments to maintain adequate blood supplies even as they work to reduce the spread of COVID-19. This means ensuring that voluntary blood donors can continue to safely donate blood, platelets and plasma. “The need for blood is becoming critical,” said Dr. Etienne. “Health services must coordinate with donors to make appointments for blood donation, either within a health facility, or through mobile collection systems and health services.”

The risk of transmission of the new coronavirus through transfusion of blood and components is likely minimal. Respiratory viruses have never been reported to be transmitted through blood or blood components, and to date there have been no reports of COVID-19 infection in blood recipients.

“Stopping donations is not an acceptable action at this time. We must find ways to ensure that blood donations continue uninterrupted and are safe for both the donor and the recipient,” said Dr. Etienne.

She called on hospitals and blood banks to take precautionary measures to minimize any risk and prevent COVID-19 infection. This includes maintaining physical distancing and implementing adequate biosecurity practices to protect their personnel and donors.

Dr. Etienne urged countries to implement appointment systems, extend donor hours, use mobile collection systems, monitor emergency blood supplies, and reschedule elective surgeries.

She also called for ensuring the availability of critical supplies for blood collection, including personal protective equipment for health personnel, and urged health officials to inform the public about who can donate in the context of the pandemic and what measures they should take to ensure safe donation.

 

Who can donate blood during COVID-19?

  • Healthy people who have no flu-like symptoms and who have not had contact with a confirmed case of COVID-19.
  • People who have been sick, traveled or had contact with a COVID-19 case may donate one month after travel, contact or full recovery.

 

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Links:

Maintaining a safe and adequate blood supply during the pandemic outbreak of COVID-19
https://www.who.int/publications-detail/maintaining-a-safe-and-adequate-blood-supply-during-the-pandemic-outbreak-of-coronavirus-disease-(covid-19)

Information on COVID-19

www.paho.org/coronavirus