We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
As Pfizer and Moderna prepare to file for Emergency Use Authorization for their promising COVID-19 vaccines in the coming weeks, they will face unprecedented distribution challenges – in Pfizer’s case the need to hold the doses at super-cold temperatures. Read More
Pfizer announced that it has launched a delivery and distribution pilot program for its COVID-19 vaccine in four U.S. states to determine how to handle challenges posed by the candidate’s ultra-low temperature requirements. Read More
Unless a specific exemption, approval or authority applies, devices must be entered in the ARTG before they can be sold in Australia, the agency said. Read More
The FDA has updated its final guidance on the use of convalescent plasma in COVID-19 treatment and clinical trials, extending its enforcement to Feb. 28, 2021. Read More
Eli Lilly’s rheumatoid arthritis treatment Olumiant (baricitinib) reduced mortality in COVID-19 patients by 71 percent in a small clinical trial led by Sweden’s Karolinska Institutet. Read More
Moderna announced this week that its coronavirus vaccine, mRNA-1273, appears to not only be more effective than Pfizer’s candidate but has significantly less stringent temperature requirements as well, likely making distribution and storage of the vaccine an easier, less daunting task. Read More