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1. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_218/view.do?seq=33369&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=12. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_209/view.do?seq=43428&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=13. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45061&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=14. 식품의약품안전처 홈페이지 Available from: https://www.mfds.go.kr/brd/m_99/view.do?seq=45101&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=15. “FDA NEWS RELEASE: FDA Approves New Treatment For Adults With Relapsed or Refractory Large-B-Cell Lymphoma” US FDA. Accessed Feb.5, 2021 Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-relapsed-or-refractory-large-b-cell-lymphoma6. “Approval Letter: BREYANZI” US FDA. Accessed Feb.5, 2021 Available from: https://www.fda.gov/media/145712/download7. “Summary Basis for Regulatory Action Template” US FDA. Accessed Feb.5, 2021 Available from: https://www.fda.gov/media/146242/download8. “Regulatory Focus: White paper addresses immuno-oncology's growing pains” RAPS. Accessed Feb. 11, 2021 Available from: https://www.raps.org/news-and-articles/news-articles/2021/2/white-paper-addresses-immuno-oncologys-growing-pai9. “Advisory Committee Calendar: Cellular, Tissue, and Gene Therapies Advisory Committee April 15, 2021 Meeting Announcement” US FDA. Accessed Feb.17, 2021 Available from: https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-april-15-2021-meeting-announcement-04152021#event-information10. “Standards Development for Regenerative Medicine Therapies” US FDA. Accessed Feb.18, 2021 Available from: https://www.fda.gov/vaccines-blood-biologics/standards-development-regenerative-medicine-therapies11. “Approval Letter: TECTARUS” US FDA. Accessed Feb.24, 2021 Available from: https://www.fda.gov/media/146253/download12. “ CAT monthly report of application procedures, guidelines and related documents on advanced therapies” EMA. Accessed Mar. 3, 2021 Available from:https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-related-documents-advanced-therapies-february_en-7.pdf13. “Advanced therapy medicinal products (ATMPs) procedural timetables” EMA. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/submission-dates/procedural-timetables#advanced-therapy-medicinal-products-(atmps)-procedural-timetables-section14. “What’s new” EMA. Accessed Feb. 2021 Available from: https://www.ema.europa.eu/en/news-events/whats-new/2021-0215. “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure” EMA. Accessed Feb.8, 2021 Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf16. 최선례 기자. 다케다 누공성 크론병치료제 ‘알로피셀’ 日 승인신청, 약업신문(2021.2.15.) Available from: https://www.yakup.com/news/index.html?mode=view&nid=25432317. “Revision of PRECAUTIONS: Tisagenlecleucel” PMDA. Accessed Feb. 25, 2021 Available from: https://www.pmda.go.jp/english/safety/info-services/ctp/0002.html
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