한국어 자료실 안내는 README.ko.md 에 있습니다.
This is the online appendix to 『신약임상개발 — FDA 허가제도의 필수 지도』 (Essentials of Clinical Drug Development: Regulatory Perspectives) by Kyun-Seop Bae. The QR code in the "더 보기" box at the end of each chapter of the book points here.
The material in this repository is written in Korean. Unlike the code repositories of the other books in the series, there is nothing language-neutral here — it is prose and link lists, not code. What follows tells you what is in it, so that you can decide whether a translation is worth your while.
The book states only the rules that were final as of its cut-off date, 2026-08. Holding to that leaves two things that have to live outside the printed page.
- The way back to the sources. Every guidance, rule and case the book cites, listed with a direct link, and, following the book's own convention, current final documents kept separate from drafts and pending ones.
- What changes. Amendments after the cut-off date, statistics as they are updated, drafts as they are finalised. What changed, when and why is in this repository's commit history.
To that are added the practical checklists that were too long for the book (chapters 3, 4, 7, 8, 15, 16, 17).
Corrections and suggestions are welcome in Issues.
Each file is that chapter's source list; most of the sources themselves are FDA and Federal Register documents in English.
| Ch | Title | Contents |
|---|---|---|
| 1 | The US drug approval system in outline | chapter guide, sources on the legislative history |
| 2 | FDA: organisation, funding, advisory committees | 5 documents |
| 3 | Nonclinical development and GLP | 15 documents · nonclinical package gap analysis |
| 4 | The IND and interactions with FDA | 9 documents · pre-IND checklist · responding to a clinical hold |
| 5 | Clinical development strategy and clinical pharmacology | 30 documents |
| 6 | Trial design and the standard of evidence for efficacy | 26 documents |
| 7 | GCP, trial conduct, BIMO inspections | 18 documents · structure of a 483 response · ALCOA-C checklist · preparing for a Korean inspection |
| 8 | The NDA/BLA and eCTD | 8 documents · pre-submission format checklist |
| 9 | The review process | 11 documents |
| 10 | Expedited programmes and pre-approval access | 12 documents |
| 11 | Orphan drugs and paediatric development | 14 documents |
| 12 | Biologics, cell and gene therapy, biosimilars | 10 documents |
| 13 | Generics, 505(b)(2) and exclusivity | 14 documents · GDUFA III, Pre-ANDA, DMF, TE codes |
| 14 | Post-marketing safety | 18 documents |
| 15 | Quality, manufacturing and lifecycle | 12 documents · inspection-readiness checklist · classifying a change |
| 16 | Regulation of drug advertising and promotion | 10 documents · internal review checklist for promotional material · communicating off-label information |
| 17 | Korea–US comparison and a market-entry strategy | checklists by stage of entry · five common misconceptions |
- the full Korea–US correspondence table (Ch 17), and a timeline of FDA approvals held by Korean companies
- current figures for the statistics that are updated (approval counts, inspection outcomes, designation statistics)
- tracking of pending documents as they are finalised — in particular FDAMA 3.0, PDUFA VIII, ICH Q1, the biosimilar CES reform, and the resumption of CRL publication
The content of this repository is licensed CC BY-NC-ND 4.0: sharing for non-commercial purposes with attribution is free, and commercial use and derivative works are not permitted. See LICENSE.md. The official documents linked from here — FDA, the Federal Register and so on — follow each agency's own public-domain or copyright policy.
Those are code repositories, and their code, output, figures and data are usable without Korean.
| 1 Scientific Computation with R | https://github.com/AMC-CPT/SciCompR |
| 2 Scientific Inference in Clinical Trials with R | https://github.com/AMC-CPT/CTDA |
| 3 Pharmacokinetics with R | https://github.com/AMC-CPT/PKwR |
| 4 Pharmacometrics with NONMEM and R | https://github.com/AMC-CPT/PMx |