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8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
Joseph Bower1, Douglas Fast, Fabio Garofolo
1Covance Laboratories, Chantilly, VA, USA.
The 8th GCC Closed Forum for Bioanalysis convened experts to discuss the 2013 revised FDA Guidance on bioanalytical method validation. Participants consolidated feedback to provide unified comments to the Food and Drug Administration (FDA).
Area of Science:
- Bioanalysis
- Regulatory Science
- Pharmaceutical Development
Background:
- The 8th GCC Closed Forum for Bioanalysis convened in Baltimore, MD, USA, on December 5, 2013.
- The meeting immediately followed the 2013 AAPS Workshop on Quantitative Bioanalytical Methods Validation and Implementation.
Framework:
- The forum focused on discussing the draft revised Food and Drug Administration (FDA) Guidance on bioanalytical method validation, published in September 2013.
- The primary objective was to consolidate feedback from GCC members on the draft guidance.
Implementation:
- 63 senior-level participants from seven countries attended.
- Representatives from 46 bioanalytical contract research organizations (CROs) were present.
Implications:
- The event provided a unique platform for CRO bioanalytical experts to voice opinions and concerns regarding the draft FDA Guidance.
- The forum aimed to develop unified comments for submission to the FDA, influencing future regulatory standards.
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