Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA.
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| Title: | Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA. |
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| Authors: | Handa T; Graduate School of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.; Late Development Oncology TA Division, AstraZeneca K.K., Tokyo, Japan., Tanaka A; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan., Shikano M; Graduate School of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan., Wakao R; Graduate School of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan. |
| Source: | Clinical and translational science [Clin Transl Sci] 2026 Jun; Vol. 19 (6), pp. e70642. |
| Publication Type: | Journal Article; Comparative Study |
| Journal Info: | Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| ISSN: | 1752-8062 |
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| DOI: | 10.1111/cts.70642 |
