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In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

USA - June 1 2021 On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug…

David Horowitz, James R. Johnson, Philip Katz.

FDA offers guidance on clinical trial waivers for investigators at non-U.S. sites

USA - May 24 2021 On May 19, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Frequently Asked Questions Statement of Investigator (Form FDA…

Heidi Gertner, Arne Thiermann.

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, Susan M. Cook, Mike Druckman, Jane Kalinina, Lowell Zeta.

First company receives FDA violation notice for submission omission

USA - April 29 2021 On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required…

Heidi Gertner, David Horowitz, Bert Lao, Blake E. Wilson.

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

USA - April 15 2021 On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug…

Christopher Fanelli, James R. Johnson, Matthew Johnson, Scott Kaplan, Daniel J. Roberts, Lowell Zeta.