Categories
rss

WHO: Mask use in the context of COVID-19: interim guidance, 1 December 2020

Murilo Freitas - 19:45, 1 de December de 20201,449

This document, which is an update of the guidance published on 5 June 2020, includes new scientific evidence relevant to the use of masks for reducing the spread of SARS-CoV-2, the virus  that causes COVID-19, and practical considerations. It contains updated evidence and guidance on the following:
• mask management;
• SARS-CoV-2 transmission;
• masking in health facilities in areas with community, cluster and sporadic transmission;
• mask use by the public in areas with community and cluster transmission;
• alternatives to non-medical masks for the public;
• exhalation valves on respirators and non-medical masks;
• mask use during vigorous intensity physical activity;
• essential parameters to be considered when manufacturing non-medical masks (Annex).

Mask use in the context of COVID-19: interim guidance, 1 December 2020 (who.int)

 
Categories
rss

Brazil: Learn about Anvisa’s actions to face the COVID-19 pandemic (In Portuguese)

Murilo Freitas - 11:56, 27 de November de 2020638

 

Vacina: nota de esclarecimento da Anvisa

26/11/2020 16h53

 

Vacina: Anvisa recebe documentos para submissão contínua

Empresa Pfizer protocolou documentos relativos às fases não-clínicas e clínicas I e II. A submissão contínua ainda não é o pedido de registro.

26/11/2020 13h50

 

Webinar da Anvisa: atuação da farmacovigilância na pandemia

Na terça-feira (1º/12), às 15h, a Agência irá realizar um seminário virtual sobre as ações de farmacovigilância no enfrentamento da Covid-19. Participe!

25/11/2020 09h48

 

Pandemia pode aumentar o risco de resistência microbiana

Problema pode ser agravado e acelerado por conta do uso indevido de antibióticos.

20/11/2020 09h25

 

Anvisa esclarece sobre inspeções em fábricas chinesas

Brasil irá inspecionar as plantas de produção específicas das vacinas contra Covid-19 na China.

 

https://www.gov.br/anvisa/pt-br/assuntos/paf/coronavirus

 
Categories
rss

WHO assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs)

Murilo Freitas - 12:36, 15 de June de 20201,217

WHO has a public consultation on the following document for the WHO Expert Committee on Biological Standardization (ECBS) is now open.

WHO assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs)

The 1st draft of the Collaborative procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs) has been prepared to enhance timely access to WHO-prequalified products in countries, to ensure that the product in countries is the same as the one which is WHO-prequalified and to provide a model for regulatory information exchange between countries. The draft document has been updated based on the informal consultation with experts from the National Regulatory Authorities which was conducted in November 2019 during the WHO Workshop on Collaborative Registration Procedure for Diagnostics.

WHO are now publishing this draft to get the feedback from a broad audience of relevant government authorities, manufacturers, and other experts. DEADLINE for submission of comment: 15 July 2020. Please send comments to: gunlud@who.int. 

You could download the document directly by clicking on the following link: https://www.who.int/biologicals/Collaborative_Procedure_for_IVDs_for_PC.pdf?ua=1

In order to provide your comments, please use the template, https://www.who.int/biologicals/Comment_Form_CRP_diagnostics_June_2020.doc?ua=1

 
Categories
rss

PAHO: The imperative to catalyze COVID-19 ethical research – Tuesday March 31 2:00 – 3:30 pm, Washington D.C. time (In English)

Murilo Freitas - 09:47, 30 de March de 20201,372

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

 
Categories
rss

Chloroquine Phosphate Intended for Fish: FDA Letter to Stakeholders – Do Not Use as Treatment for COVID-19 in Humans

Murilo Freitas - 22:43, 28 de March de 2020947
TOPIC: Chloroquine Phosphate Intended for Fish: FDA Letter to Stakeholders – Do Not Use as Treatment for COVID-19 in Humans
AUDIENCE: Consumer, Health Professional
ISSUE: The FDA’s Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Unfortunately, we have learned that one person in the United States has died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19; his wife also became very ill.
Our primary concern during the COVID-19 pandemic is the imminent threat to the health of consumers who may take animal drugs thinking they are interchangeable with approved human drugs.

 

Go to this Safety Alert at MedWatch 

 
PRAIS 2.0