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...
Saved in:
Published in | Therapeutic innovation & regulatory science Vol. 55; no. 6; pp. 1109 - 1110 |
---|---|
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 |
Cover
Loading…
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. |
---|---|
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) |
BookMark | eNp9UttuFSEUJabG1tof8InEF1_Gcj0DPpg0p1qbNDmNl2fCAGcODQMjzDRpP8ZvlfHUS32QhGwIa629F1nPwUFM0QHwEqM3GKH2tDDKGG4QqRtRKpv7J-CI4JVomEDs4Ne5legQnJRyg-qSgrdEPAOHlSoFIe0R-L5Ow5AiXIqLk853sN6utbNeT9kbuIkmhdTfwfM89_Dc3bqQxgUKr-cu-LJz9i08i2nauQw_T26EPsLNOPnBFx97eBFSpwP85Po56ClV_XVK2fqoJ187pe3fzR7JBx3LC_B0q0NxJw_1GHz98P7L-mNztbm4XJ9dNYZxPDWdZZYabqt1KaQ1VHbMrDTSRhBBV5RJblvJqdFCO8wlMgh3LZVGUOsIIfQYvNvrjnM3OGvqAFkHNWY_1C9RSXv1-CX6nerTrZKMtoIuAq8fBHL6NrsyqerfuFBNuDQXRXiLEecYswp99Q_0Js05VnsLSlLJGRcVRfYok1Mp2W1_D4ORWhKg9glQNQHqZwLUfSXRPalUcOxd_iP9H9YPxC23xQ |
CitedBy_id | crossref_primary_10_1093_ecco_jcc_jjac135 crossref_primary_10_1080_10543406_2023_2172424 crossref_primary_10_1016_S2352_4642_22_00344_3 |
Cites_doi | 10.1200/JCO.20.02152 10.1002/cpt.1617 |
ContentType | Journal Article |
Copyright | The Drug Information Association, Inc 2021 The Drug Information Association, Inc 2021. |
Copyright_xml | – notice: The Drug Information Association, Inc 2021 – notice: The Drug Information Association, Inc 2021. |
DBID | AAYXX CITATION 7U7 C1K K9. NAPCQ 7X8 5PM |
DOI | 10.1007/s43441-021-00339-z |
DatabaseName | CrossRef Toxicology Abstracts Environmental Sciences and Pollution Management ProQuest Health & Medical Complete (Alumni) Nursing & Allied Health Premium MEDLINE - Academic PubMed Central (Full Participant titles) |
DatabaseTitle | CrossRef ProQuest Health & Medical Complete (Alumni) Nursing & Allied Health Premium Toxicology Abstracts Environmental Sciences and Pollution Management MEDLINE - Academic |
DatabaseTitleList | ProQuest Health & Medical Complete (Alumni) |
DeliveryMethod | fulltext_linktorsrc |
Discipline | Medicine Pharmacy, Therapeutics, & Pharmacology |
EISSN | 2168-4804 |
EndPage | 1110 |
ExternalDocumentID | 10_1007_s43441_021_00339_z |
GroupedDBID | -MK 01A 0R~ 2JY 3V. 406 53G 7RV 7X7 88I 8AF 8AO 8FE 8FH 8FI 8FJ 8FW 8G5 AADTT AAFGU AAGHA AAHNG AAICN AARDL AATNV AAUYE AAWVI AAYFA ABAWP ABCCA ABECU ABFTV ABJNI ABKAS ABKCH ABMQK ABNLC ABQXT ABTEG ABTKH ABUWG ACDXX ACGFS ACGOD ACHSB ACIGE ACLZU ACPRK ACSBE ACTQU ACTTH ACVWB ACWMK ADBBV ADGDL ADOXG ADTPH ADYFF AEFTE AEMII AENEX AERKM AERUW AESKC AESTI AEUHG AEUIJ AEWDL AFKRA AFNRJ AFQWF AFRAH AGMZJ AGTGN AHMBA AIFIH AILAN AJDOV AJMMQ AJZVZ ALMA_UNASSIGNED_HOLDINGS AMXSW AMYLF ARTOV AUTPY AYAKG AZQEC BBNVY BCU BEC BENPR BFDSU BHPHI BKEYQ BKOMP BKSCU BPHCQ BVXVI CCPQU DD0 DF. DH~ DPUIP DV7 DWQXO EBLON EBS EJD EX3 FNLPD FYUFA GNUQQ GROUPED_SAGE_PREMIER_JOURNAL_COLLECTION GUQSH HCIFZ HF~ HMCUK HZ~ IKXTQ IWAJR J8X JCYGO JZLTJ K.F KOV LK8 LLZTM M2O M2P M2Q M7P NAPCQ NPVJJ NQJWS O9- P.B PQQKQ PROAC PT4 ROL RSV S01 S0X SCNPE SFC SJFOW SNE SNPRN SOHCF SOJ SRMVM SSLCW UKHRP WOW Z7S Z7U Z83 Z87 ZCA ZMTXR AACDK AAJBT AASML AAYXX ABAKF ACAOD ACDTI ACUIR ACZOJ AEFQL AEMSY AFBBN AGQEE AIGIU ALIPV CITATION FIGPU H13 SJYHP --- .2G 29G 5GY 7U7 8R4 8R5 BES C1K E3Z F5P K9. P2P PRG Q2X SJN TAE VQ3 7X8 5PM |
ID | FETCH-LOGICAL-c451t-bd4d3c5d480989dc39b4c6a0ac828363495d7953ca8ae1590c01b739c83de2223 |
ISSN | 2168-4790 |
IngestDate | Tue Sep 17 21:08:06 EDT 2024 Thu Oct 24 23:08:41 EDT 2024 Thu Oct 10 22:13:27 EDT 2024 Thu Sep 12 19:30:49 EDT 2024 Sat Dec 16 12:08:53 EST 2023 |
IsDoiOpenAccess | false |
IsOpenAccess | true |
IsPeerReviewed | true |
IsScholarly | true |
Issue | 6 |
Language | English |
LinkModel | OpenURL |
MergedId | FETCHMERGED-LOGICAL-c451t-bd4d3c5d480989dc39b4c6a0ac828363495d7953ca8ae1590c01b739c83de2223 |
Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
OpenAccessLink | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437832 |
PMID | 34498227 |
PQID | 2579395458 |
PQPubID | 30058 |
PageCount | 2 |
ParticipantIDs | pubmedcentral_primary_oai_pubmedcentral_nih_gov_9437832 proquest_miscellaneous_2571055114 proquest_journals_2579395458 crossref_primary_10_1007_s43441_021_00339_z springer_journals_10_1007_s43441_021_00339_z |
PublicationCentury | 2000 |
PublicationDate | 2021-11-01 |
PublicationDateYYYYMMDD | 2021-11-01 |
PublicationDate_xml | – month: 11 year: 2021 text: 2021-11-01 day: 01 |
PublicationDecade | 2020 |
PublicationPlace | Cham |
PublicationPlace_xml | – name: Cham – name: Thousand Oaks |
PublicationTitle | Therapeutic innovation & regulatory science |
PublicationTitleAbbrev | Ther Innov Regul Sci |
PublicationYear | 2021 |
Publisher | Springer International Publishing Springer Nature B.V |
Publisher_xml | – name: Springer International Publishing – name: Springer Nature B.V |
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 |
References_xml | – volume: 38 start-page: 4227 issue: 36 year: 2020 ident: 339_CR2 publication-title: J Clin Oncol doi: 10.1200/JCO.20.02152 contributor: fullname: G Reaman – volume: 107 start-page: 507 issue: 3 year: 2020 ident: 339_CR3 publication-title: Clin Pharmacol Ther doi: 10.1002/cpt.1617 contributor: fullname: T Teixeira – ident: 339_CR1 |
SSID | ssj0000985728 |
Score | 2.3025749 |
Snippet | The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development,... |
SourceID | pubmedcentral proquest crossref springer |
SourceType | Open Access Repository Aggregation Database Publisher |
StartPage | 1109 |
SubjectTerms | Commentary Coordination Drug development Drug Safety and Pharmacovigilance Medicine Oncology Pediatrics Pharmacotherapy Pharmacy |
Title | Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans |
URI | https://link.springer.com/article/10.1007/s43441-021-00339-z https://www.proquest.com/docview/2579395458 https://search.proquest.com/docview/2571055114 https://pubmed.ncbi.nlm.nih.gov/PMC9437832 |
Volume | 55 |
hasFullText | 1 |
inHoldings | 1 |
isFullTextHit | |
isPrint | |
link | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1Lb9NAEF6F9MIF8RSBghYJ9dIa2fE69nJrC6VC0FZVK_VmrXftNggclMeh-TH8Q_4DM_vyJrQS5WIldrRrZz7PzM7OfEPI2ypveFLHyAAgh7BAkUkkKiGjhjEVM1E0TBOYfj0aHZ6zzxfZRa_3O8haWsyrd3J5Y13J_0gVzoFcsUr2DpL1g8IJ-AzyhSNIGI7_JGOs7phg1d4PnQKOu-Wg0oTrvrF93EpDsfRhurgM84N8NrwygUFdhqUzvjD-cQxqBMSvQ1OGL-TUdKzH_fj9CSxXx633NIPpVib4Lmwc8JvHoyv0gjlcK1aNvGk3ujXI3gxgIrF19JEExZcVndbChm5dkY1LLBpfmhI13THE25wv9Ux7yZ8w97Ztx2GwY5jYqj-vE4fJSAcDzVZOHZwrTBdjp9QN968Fb6ihkWE1sPag6uMbLYlJHpmxFPzFCO8Eu97xaNnZTZcrsGZOfZKjJ4TWY5QwRqnHKJf3yMYQif37ZGP3YG_vyAcFY15kue4H7B_UFnrpcs-_bmbVmepWSOv5vWub_Np3OntIHthFD901CH5EenX7mGydGNb06x0aYGO2Q7foScenfv2E_DIwpx3MKXzrcEcdzCnCnAYopB7m76kFOUWQ03FLO5BTA3LagZyGIKeTJpxsZXgE-VNyfvDxbP8wsm1FIsmyZB5ViqlUZgogwwuuZMorJkciFrIAX3uUMp6pnGepFIWowduPZZxUecplkaoa3elnpN9O2vo5obAYl7FK8kKJmCWNEgzL3upCpHmeZ40YkG0nn_KnYY8pb4fFgGw6EZZWy8xKMKk85bi9PSBv_GX4f3BjT7T1ZKF_g31uk4QNSL4iej8rssivXmnHV5pNnrM0B7M-IDsOJN3kt9_rizs92Utyv3ubN0l_Pl3Ur8CZn1ev7SvwB6gr-ng |
link.rule.ids | 230,315,786,790,891,27946,27947 |
linkProvider | Library Specific Holdings |
openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Common+Commentary+on+Paediatric+Oncology+Drug+Development+Published%3A+Another+Step+in+Optimising+Global+Regulatory+Coordination+of+Paediatric+Development+Plans&rft.jtitle=Therapeutic+innovation+%26+regulatory+science&rft.au=Karres%2C+Dominik&rft.au=Reaman%2C+Gregory&rft.au=Ligas%2C+Franca&rft.au=Lesa%2C+Giovanni&rft.date=2021-11-01&rft.issn=2168-4790&rft.eissn=2168-4804&rft.volume=55&rft.issue=6&rft.spage=1109&rft.epage=1110&rft_id=info:doi/10.1007%2Fs43441-021-00339-z&rft.externalDBID=n%2Fa&rft.externalDocID=10_1007_s43441_021_00339_z |
thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2168-4790&client=summon |
thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2168-4790&client=summon |
thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2168-4790&client=summon |