View in EDS HTML Full Text PDF Full Text

Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA.

Saved in:
Bibliographic Details
Title: Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA.
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
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 42316992
AccessLevel: 2
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Handa+T%22">Handa T</searchLink>; Graduate School of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.; Late Development Oncology TA Division, AstraZeneca K.K., Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Tanaka+A%22">Tanaka A</searchLink>; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Shikano+M%22">Shikano M</searchLink>; Graduate School of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Wakao+R%22">Wakao R</searchLink>; Graduate School of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.; Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22101474067%22">Clinical and translational science</searchLink> [Clin Transl Sci] 2026 Jun; Vol. 19 (6), pp. e70642.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Journal Article; Comparative Study
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22WileyBlackwell+Pub%22">WileyBlackwell Pub </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101474067 <i>Publication Model: </i>Print <i>Cited Medium: </i>Internet <i>ISSN: </i>1752-8062 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2217528054%22">17528054 </searchLink><i>NLM ISO Abbreviation: </i>Clin Transl Sci <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42316992
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1111/cts.70642
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: e70642
    Titles:
      – TitleFull: Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Handa T
      – PersonEntity:
          Name:
            NameFull: Tanaka A
      – PersonEntity:
          Name:
            NameFull: Shikano M
      – PersonEntity:
          Name:
            NameFull: Wakao R
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 06
              Text: 2026 Jun
              Type: published
              Y: 2026
          Identifiers:
            – Type: issn-electronic
              Value: 1752-8062
          Numbering:
            – Type: volume
              Value: 19
            – Type: issue
              Value: 6
          Titles:
            – TitleFull: Clinical and translational science
              Type: main
ResultId 1