Anvisa Authorizes the immediate and emergency use of 24,000 units of Monkeypox diagnostic reagents, comprising two molecular kits produced by BioManguinhos/Fiocruz.
Anvisa approves release of vaccine and medicine against monkey pox
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)
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.
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 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 Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.
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.
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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 that there are no conclusive studies proving the use of hydroxychloroquine and chloroquine as a treatment for 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.