Articles

Results 1 to 5 of 6
Most popular |Most recent


FDA and OHRP Issue Guidance Related to Research During the COVID-19 Pandemic

USA - April 13 2020 On April 8, the Office for Human Research Protections (OHRP) released guidance on human subject protections matters related to COVID-19. The guidance…

Kyle R. Gregory.

Health Law Update - January 26, 2017

USA - January 26 2017 Welcome to this week's edition of the Health Law Update...

Adam J. Higgins, B. Scott McBride, Christian B. Jones, Donna S. Clark, Elizabeth A. O'Connell, Ernessa B. McKie, Kristen McDermott Woodrum, Kyle R. Gregory, Lee H. Rosebush, Lindsay P. Holmes, Lynn Sessions, Michael A. Ferguson, Susan Feigin Harris, Thomas S. Campanella, Tyler M. Thompson, Vimala Devassy.

More Than the Leaves Are Changing: Clinical Trial Research Regulations and Policies Get a Fall Makeover

USA - October 24 2016 The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous…

Ernessa B. McKie.

Health Law Update - October 20, 2016

USA - October 20 2016 The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous…

Elizabeth A. O'Connell, Ernessa B. McKie, Kevin D. Bradberry, Vimala Devassy.

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

USA - May 5 2016 An overview of stakeholder comments on the redefinition of “biospecimen” as a “human subject” and the consent requirements for secondary use of these biospecimens.

Gregory E. Fosheim.