FDA Proposes Amendment of GLP for Non-Clinical Laboratory Studies

The FDA has proposed significant changes to the Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies in order to be more relevant to today’s practices in regards to the way studies are planned and conducted. The proposed changes especially focused on multi-site studies. 

According to the National Law Review, the following are included among the significant proposed changes by the FDA: 

  • Additional standard operating procedures (SOP) to ensure conformity with the proposed requirement for a GLP Quality System;
  • Revised definitions of "testing facility" and "test site" to address the functions and requirements unique to multi-site studies; and
  • Updated responsibilities assigned to key roles in a GLP study, including but not limited to the Sponsor, Management, Study Director, Quality Assurance Unit, Principal Investigators, and contributing scientists. 
Previous
Previous

Review Published for Nanomaterial Products and Application in Agriculture, Feed, and Food in the European Union (EU)

Next
Next

White House Releases Documents to Modernize Biotechnology Products