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FDA transition plan for COVID-19 medical devices requests new submissions to agency

USA - January 11 2022 On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers…

Lina R. Kontos, Randy Prebula, Blake E. Wilson

HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests

USA - November 22 2021 On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented…

Susan D. Tiedy-Stevenson, Brooke Bumpers, Randy Prebula, Blake E. Wilson

Life sciences and health care horizons 2021

China, European Union, Global, United Kingdom, USA - February 23 2021 At the beginning of 2020, no one would have Predicted the COVID-19 pandemic and the global Health crisis it would create. Nor would they…

Steve Abrams, Lynn W. Mehler, Ernesto Federico Algaba Reyes, Jane Summerfield

HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority

USA - August 23 2020 On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug…

Janice M. Hogan, Susan D. Tiedy-Stevenson, Brooke Bumpers, Jonathan S. Kahan, Randy Prebula

COVID-19: Daily Report for Life Sciences and Health Care Companies

USA - July 5 2020 The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay…

Aaron Armstrong, Hein van den Bos, Samaa Haridi, Timothy Hill, Andrew McGinty, Kent Phillips, Karl Pörnbacher, Cate Stetson, May Lyn Yuen, Ivan Zapien, Christine Zimmerman