405 related articles for article (PubMed ID: 21540422)
1. Availability of comparative efficacy data at the time of drug approval in the United States.
Goldberg NH; Schneeweiss S; Kowal MK; Gagne JJ
JAMA; 2011 May; 305(17):1786-9. PubMed ID: 21540422
[TBL] [Abstract][Full Text] [Related]
2. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.
Sacks LV; Shamsuddin HH; Yasinskaya YI; Bouri K; Lanthier ML; Sherman RE
JAMA; 2014 Jan 22-29; 311(4):378-84. PubMed ID: 24449316
[TBL] [Abstract][Full Text] [Related]
3. Effective Market Exclusivity of New Molecular Entities for Rare and Non-rare Diseases.
Kerr KW; Glos LJ
Pharmaceut Med; 2020 Feb; 34(1):19-29. PubMed ID: 32048213
[TBL] [Abstract][Full Text] [Related]
4. Preapproval and postapproval availability of published comparative efficacy research on biological agents.
Thomas RH; Freeman MK; Hughes PJ
Am J Health Syst Pharm; 2013 Jul; 70(14):1250-5. PubMed ID: 23820463
[TBL] [Abstract][Full Text] [Related]
5. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.
Hao J; Rodriguez-Monguio R; Seoane-Vazquez E
PLoS One; 2015; 10(10):e0140708. PubMed ID: 26469277
[TBL] [Abstract][Full Text] [Related]
6. The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs.
Ladanie A; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
Trials; 2018 Sep; 19(1):505. PubMed ID: 30231912
[TBL] [Abstract][Full Text] [Related]
7. Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source.
Withycombe B; Ovenell M; Meeker A; Ahmed SM; Hartung DM
J Clin Epidemiol; 2016 Sep; 77():78-83. PubMed ID: 27108488
[TBL] [Abstract][Full Text] [Related]
8. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
[TBL] [Abstract][Full Text] [Related]
9. Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?
Richey EA; Lyons EA; Nebeker JR; Shankaran V; McKoy JM; Luu TH; Nonzee N; Trifilio S; Sartor O; Benson AB; Carson KR; Edwards BJ; Gilchrist-Scott D; Kuzel TM; Raisch DW; Tallman MS; West DP; Hirschfeld S; Grillo-Lopez AJ; Bennett CL
J Clin Oncol; 2009 Sep; 27(26):4398-405. PubMed ID: 19636013
[TBL] [Abstract][Full Text] [Related]
10. Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products.
Moore TJ; Mouslim MC; Blunt JL; Alexander GC; Shermock KM
JAMA Intern Med; 2021 Jan; 181(1):52-60. PubMed ID: 33031559
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. Patent life of antiretroviral drugs approved in the US from 1987 to 2007.
Rodriguez-Monguio R; Seoane-Vazquez E
AIDS Care; 2009 Jun; 21(6):760-8. PubMed ID: 19499381
[TBL] [Abstract][Full Text] [Related]
13. Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.
Downing NS; Shah ND; Neiman JH; Aminawung JA; Krumholz HM; Ross JS
Trials; 2016 Apr; 17():199. PubMed ID: 27079511
[TBL] [Abstract][Full Text] [Related]
14. Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.
Naci H; Wouters OJ; Gupta R; Ioannidis JPA
Milbank Q; 2017 Jun; 95(2):261-290. PubMed ID: 28589600
[TBL] [Abstract][Full Text] [Related]
15. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.
Qureshi ZP; Seoane-Vazquez E; Rodriguez-Monguio R; Stevenson KB; Szeinbach SL
Pharmacoepidemiol Drug Saf; 2011 Jul; 20(7):772-7. PubMed ID: 21574210
[TBL] [Abstract][Full Text] [Related]
16. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
Kesselheim AS; Myers JA; Avorn J
JAMA; 2011 Jun; 305(22):2320-6. PubMed ID: 21642684
[TBL] [Abstract][Full Text] [Related]
17. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
Downing NS; Aminawung JA; Shah ND; Krumholz HM; Ross JS
JAMA; 2014 Jan 22-29; 311(4):368-77. PubMed ID: 24449315
[TBL] [Abstract][Full Text] [Related]
18. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.
Zhang AD; Puthumana J; Downing NS; Shah ND; Krumholz HM; Ross JS
JAMA Netw Open; 2020 Apr; 3(4):e203284. PubMed ID: 32315070
[TBL] [Abstract][Full Text] [Related]
19. Participation of women in clinical trials for new drugs approved by the food and drug administration in 2000-2002.
Yang Y; Carlin AS; Faustino PJ; Motta MI; Hamad ML; He R; Watanuki Y; Pinnow EE; Khan MA
J Womens Health (Larchmt); 2009 Mar; 18(3):303-10. PubMed ID: 19243271
[TBL] [Abstract][Full Text] [Related]
20. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.
Rathi VK; Wang B; Ross JS; Downing NS; Kesselheim AS; Gray ST
Otolaryngol Head Neck Surg; 2017 Apr; 156(4):683-692. PubMed ID: 28116974
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
