Feb 1, 2021 | FDA, News, Regulatory
ADMA Biologics announced today (2/1) that the U.S. Food and Drug Administration (FDA) has granted approval for the ADMA BioCenters Plasma Collection Facility in Knoxville, Tennessee. Adam Grossman, President and Chief Executive Officer of ADMA, stated, “The approval... 
Jan 29, 2021 | EMA, News, Regulatory
The European Medicine’s Agency (EMA) announced today (1/29) it’s approval of the AstraZeneca and University of Oxford’s COVID-19 vaccine. The approval marks the third vaccine passed by the EMA. The vaccine is administered as two doses, with the second coming between 4... 
Jan 28, 2021 | News, Regulatory
For the first time in history, the U.S. Food and Drug Administration (FDA) has placed a countrywide import alert for all hand sanitizers from Mexico due to concerns of methanol contamination. Hand sanitizers that are contaminated with methanol are known to result in a... 
Jan 27, 2021 | News, Regulatory
As an update to the previous release late last year, Japan’s regulatory body, the Pharmaceutical and Medical Device Agency (PMDA), has released its translated English version of the process for conducting remote compliance inspections for drugs and regenerative... 
Jan 26, 2021 | News, Regulatory
Yesterday (1/25), Australia’s Therapeutic Good Administration (TGA) authorized Pfizer and BioNTech’s COVID-19 vaccine. The provisional approval is the first for COVID-19 vaccines in Australia’s market for individuals 16 years and older and is expected to be... 
Jan 25, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune...
