Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans
The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this...
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| Published in | Therapeutic innovation & regulatory science Vol. 55; no. 6; pp. 1109 - 1110 |
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| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Cham
Springer International Publishing
01.11.2021
Springer Nature B.V |
| Subjects | |
| Online Access | Get full text |
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| Abstract | The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this document is to guide deliberations and permit focused discussions at the monthly paediatric cluster calls, allowing early regulatory coordination of global development plans. The differences in regulations related to timeline are not considered posing a barrier in that regard. |
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| AbstractList | The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this document is to guide deliberations and permit focused discussions at the monthly paediatric cluster calls, allowing early regulatory coordination of global development plans. The differences in regulations related to timeline are not considered posing a barrier in that regard. |
| Author | McCune, Susan Bax, Ralph Malli, Suzanne Lesa, Giovanni Temeck, Jean Reaman, Gregory Karres, Dominik Ligas, Franca |
| AuthorAffiliation | 3 Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA), Silver Spring, USA 1 Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands 2 Oncology Center of Excellence, Office of the Commissioner, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, USA |
| AuthorAffiliation_xml | – name: 2 Oncology Center of Excellence, Office of the Commissioner, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, USA – name: 3 Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA), Silver Spring, USA – name: 1 Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands |
| Author_xml | – sequence: 1 givenname: Dominik surname: Karres fullname: Karres, Dominik email: Dominik.Karres@ema.europa.eu organization: Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA) – sequence: 2 givenname: Gregory surname: Reaman fullname: Reaman, Gregory organization: Oncology Center of Excellence, Office of the Commissioner, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA) – sequence: 3 givenname: Franca surname: Ligas fullname: Ligas, Franca organization: Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA) – sequence: 4 givenname: Giovanni surname: Lesa fullname: Lesa, Giovanni organization: Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA) – sequence: 5 givenname: Susan surname: McCune fullname: McCune, Susan organization: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA) – sequence: 6 givenname: Suzanne surname: Malli fullname: Malli, Suzanne organization: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA) – sequence: 7 givenname: Ralph surname: Bax fullname: Bax, Ralph organization: Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department, European Medicines Agency (EMA) – sequence: 8 givenname: Jean surname: Temeck fullname: Temeck, Jean organization: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration (FDA) |
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| Cites_doi | 10.1200/JCO.20.02152 10.1002/cpt.1617 |
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| Copyright | The Drug Information Association, Inc 2021 The Drug Information Association, Inc 2021. |
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| References | European Medicines Agency. https://www.ema.europa.eu/en/documents/other/common-commentary-ema/fda-common-issues-requested-discussion-respective-agency-ema/pdco-fda-concerning-paediatric-oncology-development-plans-paediatric-investigation-plans-pips_en.pdf. Accessed 30 June 2021. TeixeiraTKwederSLSaint-RaymondAAre the European Medicines Agency, US Food and Drug Administration, and other international regulators talking to each other?Clin Pharmacol Ther2020107350755110.1002/cpt.1617 ReamanGKarresDLigasFAccelerating the global development of pediatric cancer drugs: a call to coordinate the submissions of pediatric investigation plans and pediatric study plans to the European Medicines Agency and US Food and Drug AdministrationJ Clin Oncol202038364227423010.1200/JCO.20.02152 T Teixeira (339_CR3) 2020; 107 339_CR1 G Reaman (339_CR2) 2020; 38 |
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| Title | Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans |
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