Results 6 to 10 of 47

FDA invites comments on xenotransplantation product regulatory standards ahead of public meeting

USA - June 22 2022 On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies…

Yetunde (Oni) Fadahunsi

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

USA - July 14 2021 On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the…

Lowell Zeta

Time’s up: New enforcement era for regenerative medicines begins June 1

USA - May 7 2021 On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to…

Thomas Beimers, Robert Church, Susan M. Cook, Jane Kalinina, Lowell Zeta

FDA extends enforcement discretion period for regenerative medicines, citing COVID-19 challenges

USA - July 20 2020 Today, the U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and…

Robert Church, David Horowitz, Scott Kaplan, Randy Prebula

The global impact of COVID-19 on clinical trials and countermeasure development

Global - March 16 2020 The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national…

Hein van den Bos, Robert Church, Lauren S. Colton, William F. Ferreira, Riccardo Fruscalzo, Heidi Gertner, David Horowitz, Susan S. Lee, Meredith Manning, Jane Summerfield, Blake E. Wilson, Justin Yu