158 related articles for article (PubMed ID: 35947814)
1. The Critical Role of Academic Clinical Trials in Pediatric Cancer Drug Approvals: Design, Conduct, and Fit for Purpose Data for Positive Regulatory Decisions.
De Wilde B; Barry E; Fox E; Karres D; Kieran M; Manlay J; Ludwinski D; Reaman G; Kearns P
J Clin Oncol; 2022 Oct; 40(29):3456. PubMed ID: 35947814
[TBL] [Abstract][Full Text] [Related]
2. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.
Ghadanian M; Schafheutle E
Ther Innov Regul Sci; 2024 Jan; 58(1):79-113. PubMed ID: 37861859
[TBL] [Abstract][Full Text] [Related]
3. The future of Cochrane Neonatal.
Soll RF; Ovelman C; McGuire W
Early Hum Dev; 2020 Nov; 150():105191. PubMed ID: 33036834
[TBL] [Abstract][Full Text] [Related]
4. Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations.
Barry E; Walsh JA; Weinrich SL; Beaupre D; Blasi E; Arenson DR; Jacobs IA
Paediatr Drugs; 2021 Jul; 23(4):381-394. PubMed ID: 34173206
[TBL] [Abstract][Full Text] [Related]
5. Transparent collaboration between industry and academia can serve unmet patient need and contribute to reproductive public health.
D'Hooghe T
Hum Reprod; 2017 Aug; 32(8):1549-1555. PubMed ID: 28854594
[TBL] [Abstract][Full Text] [Related]
6. Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation.
Hopkins AM; Modi ND; Rockhold FW; Hoffmann T; Menz BD; Veroniki AA; McKinnon RA; Rowland A; Swain SM; Ross JS; Sorich MJ
J Clin Epidemiol; 2024 Mar; 167():111263. PubMed ID: 38219810
[TBL] [Abstract][Full Text] [Related]
7. Guidelines, editors, pharma and the biological paradigm shift.
Singh AR; Singh SA
Mens Sana Monogr; 2007 Jan; 5(1):27-30. PubMed ID: 22058616
[TBL] [Abstract][Full Text] [Related]
8. Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.
Pearson ADJ; Barry E; Mossé YP; Ligas F; Bird N; de Rojas T; Zimmerman ZF; Wilner K; Woessmann W; Weiner S; Weigel B; Venkatramani R; Valteau D; Trahair T; Smith M; Singh S; Selvaggi G; Scobie N; Schleiermacher G; Richardson N; Park J; Nysom K; Norga K; Merino M; McDonough J; Matloub Y; Marshall LV; Lowe E; Lesa G; Irwin M; Karres D; Gajjar A; Doz F; Fox E; DuBois SG; Donoghue M; Casanova M; Caron H; Buenger V; Bradford D; Blanc P; Barone A; Reaman G; Vassal G
Eur J Cancer; 2021 Nov; 157():198-213. PubMed ID: 34536944
[TBL] [Abstract][Full Text] [Related]
9. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Salcher-Konrad M; Naci H; Davis C
Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
[TBL] [Abstract][Full Text] [Related]
10. Licensing of Orphan Medicinal Products-Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021.
Naumann-Winter F; Wolter F; Hermes U; Malikova E; Lilienthal N; Meier T; Kalland ME; Magrelli A
Front Pharmacol; 2022; 13():920336. PubMed ID: 36034814
[No Abstract] [Full Text] [Related]
11. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.
J Manag Care Spec Pharm; 2017 Jan; 23(1):105-112. PubMed ID: 28025919
[TBL] [Abstract][Full Text] [Related]
12. Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration.
Modi ND; Abuhelwa AY; McKinnon RA; Boddy AV; Haseloff M; Wiese MD; Hoffmann TC; Perakslis ED; Rowland A; Sorich MJ; Hopkins AM
JAMA Oncol; 2022 Sep; 8(9):1310-1316. PubMed ID: 35900732
[TBL] [Abstract][Full Text] [Related]
13. Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.
Lythgoe MP; Desai A; Gyawali B; Savage P; Krell J; Warner JL; Khaki AR
JAMA Netw Open; 2022 Jun; 5(6):e2216183. PubMed ID: 35687337
[TBL] [Abstract][Full Text] [Related]
14. Current models, challenges and best practices for work conducted between European academic cooperative groups and industry.
Stahel RA; Lacombe D; Cardoso F; Casali PG; Negrouk A; Marais R; Hiltbrunner A; Vyas M;
ESMO Open; 2020 Mar; 5(2):. PubMed ID: 32213534
[TBL] [Abstract][Full Text] [Related]
15. Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.
Hata T; Nakamura K; Yonemori K; Noguchi E; Watanabe M; Sohn J; Lu YS; Yap YS; Tamura K; Fujiwara Y
Clin Transl Sci; 2021 May; 14(3):1015-1025. PubMed ID: 33382914
[TBL] [Abstract][Full Text] [Related]
16. Strategies to facilitate adolescent access to medicines: Improving regulatory guidance.
Bucci-Rechtweg C; Siapkara A; An Haack Bonnet K; Corriol Rohou S; Haf Davies E; Dehlinger Kremer M; Gamalo M; Moreno C; Nelson RM; Thomas Turner R
Clin Trials; 2023 Feb; 20(1):13-21. PubMed ID: 36341541
[TBL] [Abstract][Full Text] [Related]
17. The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.
Bloom D; Beetsch J; Harker M; Hesterlee S; Moreira P; Patrick-Lake B; Selig W; Sherman J; Smith SK; Valentine JE; Roberts JN
Ther Innov Regul Sci; 2018 Mar; 52(2):206-213. PubMed ID: 29714514
[TBL] [Abstract][Full Text] [Related]
18. The project data sphere initiative: accelerating cancer research by sharing data.
Green AK; Reeder-Hayes KE; Corty RW; Basch E; Milowsky MI; Dusetzina SB; Bennett AV; Wood WA
Oncologist; 2015 May; 20(5):464-e20. PubMed ID: 25876994
[TBL] [Abstract][Full Text] [Related]
19. How to anticipate the assessment of the public health benefit of new medicines?
Massol J; Puech A; Boissel JP;
Therapie; 2007; 62(5):427-35. PubMed ID: 18206104
[TBL] [Abstract][Full Text] [Related]
20. Lessons learned from independent central review.
Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
