Brazil’s Anvisa confirms “Superfungus” Outbreak of Candida Auris in Brazil

Brazil’s National Health Surveillance Agency (Anvisa) informs that, on Tuesday (11/1), the third outbreak of the Candida auris fungus in Brazil was confirmed. The case occurred in a hospital in Pernambuco (PE)
Anvisa approves new HIV treatment

Brazil’s National Health Surveillance Agency (Anvisa) has approved a new drug for the treatment of HIV that combines two different substances in a single tablet.
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).
China’s NMPA introduces new guidance for COVID-19 drug clinical trials

China’s National Medical Product Administration (NMPA) released on July 2020 a guideline focused on the emergency approval of the new COVID-19 virus drugs and vaccines for sponsors and researchers.
United Kingdom’s MHRA releases a list of exempted medical devices

United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.
Steps to take if you have a COVID-19 confirmed positive worker: CDC Recommendations

The FDA encourages and outlines major steps to be taken as per the CDC recommendations to help prevent and slow the COVID-19 in the office.
Global Regulatory Partners is Joining the Fight Against Coronavirus (COVID-19)

Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) -Contact US to Learn More
FDA Emergency Use Authorization (EUA) for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators

To increase the availability of Face Masks Intended for the protection of health care professionals the FDA will expedite the review of unapproved devices under the Emergency Use Authorization (EUA) process.
Anvisa Clarifies on use of Chloroquine and Hydroxychloroquine as potential treatments of COVID-19

ANVISA clarifies that there are no conclusive studies proving the use of hydroxychloroquine and chloroquine as a treatment for COVID-19.
Do You Qualify for FDA Emergency Use Authorization (EUA) for Coronavirus (COVID-19)?

If you are a Medical Device, or Pharmaceutical that has the potential to diagnose or treat Coronavirus, you may qualify for FDA Emergency Use Authorization (EUA) in USA.
FDA publishes guidance on conducting clinical trials during COVID-19 Pandemic.

On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.
China’s Communist Party held a meeting on March 4 to study the current state of Coronavirus in China.

The Standing Committee of the Political Bureau of the Central Committee of the Communist Party of China held a meeting on March 4 which was presided over by General Secretary Xi Jinping to study the current priorities for the prevention and control of the novel coronavirus epidemic and the stabilization of economic and social operations