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COVID-19 guidance and ongoing research in the Americas

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PAHO has developed a searchable database that provides access to technical guidelines, scientific publications, and ongoing research protocols from the Americas and affected countries worldwide regarding the coronavirus disease (COVID-19) pandemic.

Recommendations and guidance from the Pan American Health Organization and the World Health Organization are also included, making it a useful platform of trusted information for decision and policy-making authorities, researchers, health professionals, and individuals.

Click here to access the page

 
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FDA: actions related to COVID-19

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

 
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WHO: Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease (COVID-19)

This document provides interim guidance on the management of the blood supply in response to the pandemic outbreak of coronavirus disease (COVID-19). It is intended for blood services, national health authorities, and others responsible for the provision of blood and blood components and integration of the blood system within the public health system. WHO will continue to update this guidance as new information becomes available.

Please, go to https://apps.who.int/iris/rest/bitstreams/1272656/retrieve

 

REFERENCE NUMBERS

WHO REFERENCE NUMBER: WHO/2019-nCoV/BloodSupply/2020.1
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PAHO: Ethics guidance on issues raised by the novel coronavirus disease (COVID-19) pandemic 

 

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

 
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FDA: Investigational COVID-19 Convalescent Plasma – Emergency Investigational New Drug Applications

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.

 
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Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening

Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level.
Additional information:

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