Emergency Medicine

FDA Grants Emergency Use Authorization to Yale for COVID-19 Test

by Samantha McGrail

FDA recently issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 test. For more coronavirus updates, visit our resource page, updated twice...

Members of Congress Demand Transparency of Operation Warp Speed

by Samantha McGrail

Twenty-four members of Congress demand increased oversight and transparency of Operation Warp Speed vaccine development program in an official letter to HHS Secretary Alex Azar. In the letter, the...

Emergency Use Authorization Issued for COVID-19 Pooled Testing

by Samantha McGrail

FDA recently reissued an Emergency Use Authorization (EUA) to Quest Diagnostics for its sample COVID-19 pooled testing tool. For more coronavirus updates, visit our resource page, updated twice...

FDA Releases Guidance on COVID-19 Vaccine Development

by Samantha McGrail

FDA recently issued guidance to assist sponsors with COVID-19 vaccine development development and licensure of their products. The guidance will be effective for the remainder of the public health...

FDA Grants Emergency Use Authorization for COVID-19 Serology Test

by Samantha McGrail

FDA recently issued an Emergency Use Authorization (EUA) for Abbott’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.  For more coronavirus updates, visit...

FDA Approves Selumetinib for Rare Pediatric Neurofibromatosis

by Samantha McGrail

FDA recently approved the first treatment for pediatric patients with neurofibromatosis phase 1 (NF1), a rare disease that affects children.  NF1 is a rare, progressive condition of the nervous...