160 related articles for article (PubMed ID: 28983992)
1. Registries supporting new drug applications.
Jonker CJ; van den Berg HM; Kwa MSG; Hoes AW; Mol PGM
Pharmacoepidemiol Drug Saf; 2017 Dec; 26(12):1451-1457. PubMed ID: 28983992
[TBL] [Abstract][Full Text] [Related]
2. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.
Bouvy JC; Blake K; Slattery J; De Bruin ML; Arlett P; Kurz X
Pharmacoepidemiol Drug Saf; 2017 Dec; 26(12):1442-1450. PubMed ID: 28345151
[TBL] [Abstract][Full Text] [Related]
3. Drug Registries and Approval of Drugs: Promises, Placebo, or a Real Success?
Jonker CJ; Kwa MSG; van den Berg HM; Hoes AW; Mol PGM
Clin Ther; 2018 May; 40(5):768-773. PubMed ID: 29709456
[TBL] [Abstract][Full Text] [Related]
4. Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.
Köhler M; Haag S; Biester K; Brockhaus AC; McGauran N; Grouven U; Kölsch H; Seay U; Hörn H; Moritz G; Staeck K; Wieseler B
BMJ; 2015 Feb; 350():h796. PubMed ID: 25722024
[TBL] [Abstract][Full Text] [Related]
5. Ophthalmic medicine regulatory approvals through the European Centralised Procedure, 1999-2017: Clinical efficacy considerations.
Morgan-Warren PJ
Eur J Ophthalmol; 2020 Mar; 30(2):321-349. PubMed ID: 30832499
[TBL] [Abstract][Full Text] [Related]
6. Post-approval Studies for Rare Disease Treatments and Orphan Drugs.
Maier WC; Christensen RA; Anderson P
Adv Exp Med Biol; 2017; 1031():197-205. PubMed ID: 29214573
[TBL] [Abstract][Full Text] [Related]
7. Orphan Drug Regulation: A missed opportunity for children and adolescents with cancer.
Vassal G; Kearns P; Blanc P; Scobie N; Heenen D; Pearson A
Eur J Cancer; 2017 Oct; 84():149-158. PubMed ID: 28818704
[TBL] [Abstract][Full Text] [Related]
8. Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003.
Motola D; De Ponti F; Rossi P; Martini N; Montanaro N
Br J Clin Pharmacol; 2005 Apr; 59(4):475-8. PubMed ID: 15801943
[TBL] [Abstract][Full Text] [Related]
9. Patient Registries: An Underused Resource for Medicines Evaluation : Operational proposals for increasing the use of patient registries in regulatory assessments.
McGettigan P; Alonso Olmo C; Plueschke K; Castillon M; Nogueras Zondag D; Bahri P; Kurz X; Mol PGM
Drug Saf; 2019 Nov; 42(11):1343-1351. PubMed ID: 31302896
[TBL] [Abstract][Full Text] [Related]
10. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
11. [New drugs and European procedures of approval. The European Agency for the Evaluation of Medicinal Products' role].
Ainsworth MA
Ugeskr Laeger; 2003 Apr; 165(16):1648-9. PubMed ID: 12756819
[TBL] [Abstract][Full Text] [Related]
12. Approvals of drugs with uncertain benefit-risk profiles in Europe.
Banzi R; Gerardi C; Bertele' V; Garattini S
Eur J Intern Med; 2015 Oct; 26(8):572-84. PubMed ID: 26342723
[TBL] [Abstract][Full Text] [Related]
13. [Registration of new medicinal products in Europe].
Singer E
Onkologie; 2008; 31 Suppl 2():64-6. PubMed ID: 18487872
[TBL] [Abstract][Full Text] [Related]
14. 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]
15. 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]
16. Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations.
Tsuji K; Tsutani K
J Clin Pharm Ther; 2010 Jun; 35(3):289-301. PubMed ID: 20848767
[TBL] [Abstract][Full Text] [Related]
17. Limitations of drug registries to evaluate orphan medicinal products for the treatment of lysosomal storage disorders.
Hollak CE; Aerts JM; Aymé S; Manuel J
Orphanet J Rare Dis; 2011 Apr; 6():16. PubMed ID: 21496291
[TBL] [Abstract][Full Text] [Related]
18. Comparing patient access to pharmaceuticals in the UK and US.
Cohen J; Cairns C; Paquette C; Faden L
Appl Health Econ Health Policy; 2006; 5(3):177-87. PubMed ID: 17132032
[TBL] [Abstract][Full Text] [Related]
19. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.
Giannuzzi V; Landi A; Bosone E; Giannuzzi F; Nicotri S; Torrent-Farnell J; Bonifazi F; Felisi M; Bonifazi D; Ceci A
BMJ Open; 2017 Sep; 7(9):e017358. PubMed ID: 28893754
[TBL] [Abstract][Full Text] [Related]
20. An update on the first decade of the European centralized procedure: how many innovative drugs?
Motola D; De Ponti F; Poluzzi E; Martini N; Rossi P; Silvani MC; Vaccheri A; Montanaro N
Br J Clin Pharmacol; 2006 Nov; 62(5):610-6. PubMed ID: 16796703
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
