796 related articles for article (PubMed ID: 28468750)
1. 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]
2. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study.
Wallach JD; Ciani O; Pease AM; Gonsalves GS; Krumholz HM; Taylor RS; Ross JS
BMC Med; 2018 Mar; 16(1):45. PubMed ID: 29562926
[TBL] [Abstract][Full Text] [Related]
3. 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]
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. 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]
6. 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]
7. 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]
8. Postmarketing Modifications of Drug Labels for Cancer Drugs Approved by the US Food and Drug Administration Between 2006 and 2016 With and Without Supporting Randomized Controlled Trials.
Shepshelovich D; Tibau A; Goldvaser H; Molto C; Ocana A; Seruga B; Amir E
J Clin Oncol; 2018 Jun; 36(18):1798-1804. PubMed ID: 29641296
[TBL] [Abstract][Full Text] [Related]
9. Overall survival benefits of cancer drugs initially approved by the US Food and Drug Administration on the basis of immature survival data: a retrospective analysis.
Naci H; Zhang Y; Woloshin S; Guan X; Xu Z; Wagner AK
Lancet Oncol; 2024 Jun; 25(6):760-769. PubMed ID: 38754451
[TBL] [Abstract][Full Text] [Related]
10. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.
Wang B; Kesselheim AS
BMJ; 2015 Sep; 351():h4679. PubMed ID: 26400844
[TBL] [Abstract][Full Text] [Related]
11. Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.
Hwang J; Hwang TJ; Ciolino JB
BMJ Open; 2015 Jun; 5(6):e007987. PubMed ID: 26044760
[TBL] [Abstract][Full Text] [Related]
12. Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration.
Feldman D; Avorn J; Kesselheim AS
JAMA Netw Open; 2022 Apr; 5(4):e227958. PubMed ID: 35438753
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.
Goring S; Taylor A; Müller K; Li TJJ; Korol EE; Levy AR; Freemantle N
BMJ Open; 2019 Feb; 9(2):e024895. PubMed ID: 30819708
[TBL] [Abstract][Full Text] [Related]
15. Publication of clinical trials supporting successful new drug applications: a literature analysis.
Lee K; Bacchetti P; Sim I
PLoS Med; 2008 Sep; 5(9):e191. PubMed ID: 18816163
[TBL] [Abstract][Full Text] [Related]
16. Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies.
Ladanie A; Speich B; Briel M; Sclafani F; Bucher HC; Agarwal A; Ioannidis JPA; Pereira TV; Kasenda B; Hemkens LG
J Clin Epidemiol; 2019 Oct; 114():49-59. PubMed ID: 31158450
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. Accelerated approval of oncology products: the food and drug administration experience.
Johnson JR; Ning YM; Farrell A; Justice R; Keegan P; Pazdur R
J Natl Cancer Inst; 2011 Apr; 103(8):636-44. PubMed ID: 21422403
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. 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]
[Next] [New Search]