13 Mar 2025
📋FDA Reopens Comment Period for Good Clinical Practice Guidance
E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
Summary
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance for industry entitled "E6(R3) Good Clinical Practice: Annex 2," announced in the Federal Register of December 30, 2024. The Agency is taking this action to allow interested persons additional time to submit comments.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The reopening of the comment period for the draft guidance on "E6(R3) Good Clinical Practice" indicates evolving compliance and regulatory requirements that businesses, particularly in the pharmaceutical and clinical trial sectors, must adapt to. This regulatory guidance emphasizes new practices in trial design and conduct, impacting operational procedures and financial planning.