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FDA Provides Guidance on Switches to Container Closure

FDA Provides Guidance on Switches to Container Closure

Mar 5, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) provided guidance that addresses changes to the supply chain due to COVID-19, including its regulatory process for manufacturing and controls (CMS) and chemistry. Materials like glass vials, stoppers, test swabs, and...
FDA Makes Recommendations for COVID-19 Variants

FDA Makes Recommendations for COVID-19 Variants

Feb 23, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are...
FDA Approves First Ever 3D-Printed Bone Replacement

FDA Approves First Ever 3D-Printed Bone Replacement

Feb 19, 2021 | News, Regulatory

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement. The device, named Patient Specific Talus Spacer, is the only 3D-printed device in the world, and...
AstraZeneca-Oxford COVID-19 Vaccine is Granted EUA by WHO

AstraZeneca-Oxford COVID-19 Vaccine is Granted EUA by WHO

Feb 16, 2021 | News, Regulatory

The World Health Organization (WHO) announced yesterday (2/15) its approval of emergency use authorization (EUA) of the AstraZeneca-Oxford COVID-19 vaccine. The vaccine is currently approved in the UK and EU, and the WHO’s approval opens more doors for other nations...