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.
Anvisa Temporarily allows pharmacies to manufacturer and sell Hand-Sanitizer to the public
On March 18, Anvisa has authorized pharmacies to prepare and sell gel alcohol directly to the public. Anvisa intends to expand the access of these products to the population, considering the high number of pharmacies throughout Brazil
Brazil’s Anvisa Cancels Face-to-Face meeting due to Coronavirus
Anvisa announces they will be canceling Face-to Face meeting as preventative measures due to Coronovirus.
FDA New Policy on Emergency Use Authorization (EUA) of In Vitro Diagnostics of Coronavirus
On February 2020, FDA issued a Policy that allows CLIA certified high-complexity testing laboratories to use their validated diagnostic tests to detect the SARS-CoV-2 virus in specimen while they are preparing for EUA submission to FDA.