The FDA announced this public meeting to be held on February 11, 2025 from 11:00 a.m. - 3:00 p.m. ET. Registration is required (see link below). Along with the guidelines hitting the PK and CMC communities, GCPs are taking center stage.
From the announcement, Topics to be covered are likely to include:
Recent final ICH guidelines:
- Pediatric extrapolation (i.e., E11A ICH guideline). This guideline supports the development and authorisation of pediatric medicines.
- Bioequivalence (BE) for Immediate-Release Solid Oral Dosage Forms (i.e., M13A ICH guideline). This BE guideline focuses on bioequivalence study considerations and data analysis for a non-replicate study design.
Recent draft ICH guidelines:
- General Principles for Model-Informed Drug Development (i.e., M15 ICH guideline).
- Good Clinical Practice Annex 2 (i.e., E6(R3) ICH Annex 2).
Additional guidelines expected to reach milestones in coming months:
- Final Good Clinical Practice Guideline and Annex 1 (i.e., E6(R3) ICH guideline).
- Targeted Revisions of the ICH Stability Guideline Series (i.e., Q1/Q5 ICH guideline).
- Bioequivalence (BE) for Immediate-Release Solid Oral Dosage Forms (i.e., M13B ICH guideline). This draft BE guideline includes biowaiver considerations for additional strengths
#fda #HeallthCanada #ICH #GCP #BE
Joint US FDA - Health Canada ICH Public Meeting 2025
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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