Brazil’s Anvisa Releases New Technical Note on the conduct of clinical trials during the COVID-19 pandemic.
Brazil’s Anvisa issues technical note that gathers the latest guidelines on the conduct of clinical trials in the face of the new coronavirus pandemic.
EU Changes IVDR Plan due to COVID-19
The European Union’s new In Vitro Diagnostic Regulations (EU IVDR 2017/746) action is delayed due to COVID-19.
The Office of Human Research Protection Issues Guidance on the Conduct of Clinical trials During COVID-19
On April 8, 2020 the USA’s Office of Human Research Protections (OHRP) released a guidance on Human Subject Protection Regulations included under regulation 45 CRF part 46, which applies to COVID-19 response.
How to make a Home-Made Face Mask: Health Authorities Recommendations
Learn how to make a home-made face mask based on health authority recommendations around the world.
The FDA Ventilator Requirements for EUA
To face the increase demand of ventilators and other respiratory devices in USA due to the COVID-19 pandemic, US FDA released a new guidance on the FDA expedite review of new ventilator under the Emergency Use Authorization (EUA) program.
Japan’s MHLW Allows Online IRB Meetings for Coronavirus Trials
Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.
The FDA Introduces the Coronavirus Treatment Acceleration Program (CTAP)
The FDA introduces the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of safe and effective life saving treatments against Coronavirus.
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