Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.
Anvisa Authorizes the immediate and emergency use of 24,000 units of Monkeypox diagnostic reagents, comprising two molecular kits produced by BioManguinhos/Fiocruz.
The new indication is for adult patients who do not require supplemental oxygen and who are at risk of progressing to a severe case.
Brazil’s Anvisa approves resolution establishing requirements for registration, distribution, commercialization, and use of covid-19 self-tests.
Foreign and Brazilian travelers abroad must present the Negative PCR exam to the airline company responsible for the flight, before boarding
Brazil’s Anvisa approves extending the use of CoronaVac to children and adolescents aged 6 to 17 years
The emergency use authorization granted this Thursday (01/20) is valid only for the age group 6 to 17 years old.
On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.
The Resolution RDC No. 590/2021 published on December 29th, 2021, the List of Brazilian Common Denominations (DCBs). The regulation included 28 new designations and changed two.
The Ordinance No.660/2021 It would impose restrictions on exceptional and specific restrictions, measures and requirements for entry into the country, due to the risks of contamination and dissemination of the SARS-CoV-2 coronavirus (covid-19).
Amendment of Resolution No. 9/2015, which provides for clinical trials with medicines in Brazil, allows, on an emergency and temporary basis, the use of analyses performed by foreign authorities that are members of the ICH.
Among the actions the Brazilian Federal Government will offer a free training course on the subject, in addition to the campaign mascot calling attention to diagnosis and information on the subject.
From the lab to the arm: learn about the Ministry of Health’s Covid-19 vaccine trial in Brazil.