Brazil’s Anvisa authorizes Remdesivir for Pediatric- Use in the treatment of Covid-19
Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.
Brazil’s Anvisa approves new Remdesivir indication for Covid-19
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 Anvisa regulates the use of self-tests for Covid-19
Brazil’s Anvisa approves resolution establishing requirements for registration, distribution, commercialization, and use of covid-19 self-tests.
Brazil’s Anvisa approves Rules for travelers entering Brazil
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.
US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA
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.
Brazil’s Anvisa identifies positive Covid-19 case in Brazilian passenger from South Africa
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).
Distribution Process of the Covid-19 vaccines in Brazil
From the lab to the arm: learn about the Ministry of Health’s Covid-19 vaccine trial in Brazil.
WHO approves emergency use of CoronaVac, Butantan Institute’s vaccine against Covid-19
According to the WHO director-general, the vaccine is considered safe, effective and quality assured with two doses.
Anvisa approves clinical study with advanced therapy product against Covid-19
Stem cell-based product, intended for the treatment of patients with Covid-19, will be tested in Brazil.
NMPA publishes new guideline for faster approval of Medical Device
China’s State Council publishes a new Medical Device Regulation (Order no. 739) to follow conditional approvals on rare diseases treating medical devices
FioCruz reinforces the position adopted by Anvisa, EMA and WHO on vaccine safety
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.