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March 04, 2021
The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).
The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.
The agency is working to identify and obstruct scammers looking to profit from the pandemic.
The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.
March 03, 2021
The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.
March 02, 2021
Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.
The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.
FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.
March 01, 2021
Distribution of the first one-dose vaccine for COVID-19 to start in early March.
To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.