Tea Tasting Statisticians
Mission
Tea Tasting Statisticians is a practical biostatistics and regulatory science blog for MedTech, pharma, and clinical teams. We translate FDA/MFDS/ICH guidance into operational decisions for study design, evidence strategy, and submission readiness. If you are a clinician, medical affairs lead, clinical operations manager, or product owner without a statistics degree, this site is built for you.
Start Here
- Start Here: onboarding path by role and common questions.
- FDA Guidance Digest: curated, high-signal guidance summaries in Korean and English.
- Problem Index: pick a practical problem and jump to relevant posts.
Featured: FDA Guidance Digest
- Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause
Why this matters: clarifies what evidence logic regulators expect when classic RCT pathways are constrained. - FDA Guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
Why this matters: helps non-statisticians understand what must be explicit in diagnostic test reporting. - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Why this matters: shows how RWE can support device submissions and where review risk usually appears.
Who Writes This
Tea Tasting Lady
Senior biostatistician with 10+ years in regulatory science, including 7 years at MFDS and 5 years in industry.
Tea Tasting Gentleman
Biostatistician and PhD candidate in clinical epidemiology focused on diabetes, RWE, and innovative trial designs.
Browse Posts
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