257 related articles for article (PubMed ID: 29714594)
21. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
Alqahtani S; Seoane-Vazquez E; Rodriguez-Monguio R; Eguale T
Pharmacoepidemiol Drug Saf; 2015 Jul; 24(7):709-15. PubMed ID: 26013294
[TBL] [Abstract][Full Text] [Related]
22. Regulatory Review Duration and Differences in Submission Times of Drugs in the United States and Europe, 2011 to 2020.
Vokinger KN; Serra-Burriel M; Glaus CEG; Rohr UP; Hwang TJ; Dalla Torre di Sanguinetto S; Kesselheim AS
Ann Intern Med; 2023 Oct; 176(10):1413-1418. PubMed ID: 37844306
[TBL] [Abstract][Full Text] [Related]
23. Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia.
Hwang TJ; Kesselheim AS; Tibau A; Lee CC; Vokinger KN
JCO Oncol Pract; 2022 Sep; 18(9):e1522-e1532. PubMed ID: 35731996
[TBL] [Abstract][Full Text] [Related]
24. Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe.
Davenport C; Gravel P; Wang Y; Williams SA; Wieland A; Mitlak B
Ther Innov Regul Sci; 2024 May; 58(3):505-518. PubMed ID: 38341388
[TBL] [Abstract][Full Text] [Related]
25. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.
Nagai S; Ozawa K
Int J Hematol; 2016 Jul; 104(1):73-84. PubMed ID: 27084259
[TBL] [Abstract][Full Text] [Related]
26. A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.
Zeukeng MJ; Seoane-Vazquez E; Bonnabry P
Eur J Clin Pharmacol; 2018 Jun; 74(6):811-818. PubMed ID: 29470610
[TBL] [Abstract][Full Text] [Related]
27. Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.
Fürst-Ladani S; Bührer A; Fürst W; Schober-Ladani N
Handb Exp Pharmacol; 2024; 284():367-387. PubMed ID: 37017789
[TBL] [Abstract][Full Text] [Related]
28. Withdrawing FDA approval of midodrine after marketing.
Holtzman NA; Starfield B
JAMA; 2011 Feb; 305(8):781-2; author reply 782. PubMed ID: 21343575
[No Abstract] [Full Text] [Related]
29. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.
Hoekman J; Klamer TT; Mantel-Teeuwisse AK; Leufkens HG; De Bruin ML
Br J Clin Pharmacol; 2016 Jul; 82(1):213-26. PubMed ID: 26992001
[TBL] [Abstract][Full Text] [Related]
30. Preventing postmarketing changes in recommended doses and marketing withdrawals.
Peck C
Ernst Schering Res Found Workshop; 2007; (59):209-16. PubMed ID: 17117726
[TBL] [Abstract][Full Text] [Related]
31. Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products.
Hyogo A; Kaneko M; Narukawa M
J Oncol Pract; 2018 Jan; 14(1):e34-e41. PubMed ID: 29136389
[TBL] [Abstract][Full Text] [Related]
32. EU marketing authorization review of orphan and non-orphan drugs does not differ.
Putzeist M; Mantel-Teeuwisse AK; Llinares J; Gispen-De Wied CC; Hoes AW; Leufkens HG
Drug Discov Today; 2013 Oct; 18(19-20):1001-6. PubMed ID: 23835230
[TBL] [Abstract][Full Text] [Related]
33. Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.
Demirci E; Omes-Smit G; Zwiers A
Clin Transl Sci; 2023 Jul; 16(7):1127-1133. PubMed ID: 37013379
[TBL] [Abstract][Full Text] [Related]
34. Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021.
Vokinger KN; Kesselheim AS; Glaus CEG; Hwang TJ
JAMA Health Forum; 2022 Aug; 3(8):e222685. PubMed ID: 36200635
[TBL] [Abstract][Full Text] [Related]
35. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
DiMasi JA
Clin Ther; 2013 Jun; 35(6):808-18. PubMed ID: 23726388
[TBL] [Abstract][Full Text] [Related]
36. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.
Jokura Y; Yano K; Yamato M
J Tissue Eng Regen Med; 2018 Feb; 12(2):e1056-e1062. PubMed ID: 28211195
[TBL] [Abstract][Full Text] [Related]
37. Time to Entry for New Cancer Medicines: From European Union-Wide Marketing Authorization to Patient Access in Belgium, Estonia, Scotland, and Sweden.
Ferrario A
Value Health; 2018 Jul; 21(7):809-821. PubMed ID: 30005753
[TBL] [Abstract][Full Text] [Related]
38. [The use of nanotechnology in medicinal products in the light of European Union law].
Jurewicz M
Pol Merkur Lekarski; 2014 Dec; 37(222):369-72. PubMed ID: 25715580
[TBL] [Abstract][Full Text] [Related]
39. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
Borg JJ; Aislaitner G; Pirozynski M; Mifsud S
Drug Saf; 2011 Mar; 34(3):187-97. PubMed ID: 21332243
[TBL] [Abstract][Full Text] [Related]
40. Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018.
Fan M; Chan AYL; Yan VKC; Tong X; Lau LKW; Wan EYF; Tam EYT; Ip P; Lum TY; Wong ICK; Li X
Orphanet J Rare Dis; 2022 Jan; 17(1):3. PubMed ID: 34983612
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]