506 related articles for article (PubMed ID: 30264133)
1. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016.
Moore TJ; Zhang H; Anderson G; Alexander GC
JAMA Intern Med; 2018 Nov; 178(11):1451-1457. PubMed ID: 30264133
[TBL] [Abstract][Full Text] [Related]
2. Estimated costs of pivotal trials for U.S. Food and Drug Administration-approved cancer drugs, 2015-2017.
Hsiue EH; Moore TJ; Alexander GC
Clin Trials; 2020 Apr; 17(2):119-125. PubMed ID: 32114790
[TBL] [Abstract][Full Text] [Related]
3. Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015-2017: a cross-sectional study.
Moore TJ; Heyward J; Anderson G; Alexander GC
BMJ Open; 2020 Jun; 10(6):e038863. PubMed ID: 32532786
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018.
Wouters OJ; McKee M; Luyten J
JAMA; 2020 Mar; 323(9):844-853. PubMed ID: 32125404
[TBL] [Abstract][Full Text] [Related]
6. Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.
Sinha MS; Najafzadeh M; Rajasingh EK; Love J; Kesselheim AS
JAMA Intern Med; 2018 Nov; 178(11):1458-1466. PubMed ID: 30264138
[TBL] [Abstract][Full Text] [Related]
7. 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]
8. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
Dhodapkar M; Zhang AD; Puthumana J; Downing NS; Shah ND; Ross JS
JAMA Netw Open; 2021 Jun; 4(6):e2113224. PubMed ID: 34110392
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. 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]
11. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
Rathi VK; Krumholz HM; Masoudi FA; Ross JS
JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
[TBL] [Abstract][Full Text] [Related]
12. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.
Skydel JJ; Luxkaranayagam AT; Dhruva SS; Ross JS; Wallach JD
JAMA Netw Open; 2019 May; 2(5):e193410. PubMed ID: 31074812
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. Research and development costs for new drugs by therapeutic category. A study of the US pharmaceutical industry.
DiMasi JA; Hansen RW; Grabowski HG; Lasagna L
Pharmacoeconomics; 1995 Feb; 7(2):152-69. PubMed ID: 10155302
[TBL] [Abstract][Full Text] [Related]
15. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
Naci H; Smalley KR; Kesselheim AS
JAMA; 2017 Aug; 318(7):626-636. PubMed ID: 28810023
[TBL] [Abstract][Full Text] [Related]
16. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
Darrow JJ; Avorn J; Kesselheim AS
JAMA; 2020 Jan; 323(2):164-176. PubMed ID: 31935033
[TBL] [Abstract][Full Text] [Related]
17. Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020.
Mitra-Majumdar M; Gunter SJ; Kesselheim AS; Brown BL; Joyce KW; Ross M; Pham C; Avorn J; Darrow JJ
JAMA Netw Open; 2022 May; 5(5):e2212454. PubMed ID: 35579897
[TBL] [Abstract][Full Text] [Related]
18. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.
Deak D; Outterson K; Powers JH; Kesselheim AS
Ann Intern Med; 2016 Sep; 165(5):363-72. PubMed ID: 27239977
[TBL] [Abstract][Full Text] [Related]
19. Globalization of clinical trials: Variation in estimated regional costs of pivotal trials, 2015-2016.
Qiao Y; Alexander GC; Moore TJ
Clin Trials; 2019 Jun; 16(3):329-333. PubMed ID: 30922113
[TBL] [Abstract][Full Text] [Related]
20. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review.
Pease AM; Krumholz HM; Downing NS; Aminawung JA; Shah ND; Ross JS
BMJ; 2017 May; 357():j1680. PubMed ID: 28468750
[No Abstract] [Full Text] [Related]
[Next] [New Search]