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Year Number of Results
2000 1
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2017 3
2019 1
2020 1
2021 2
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Generating comparative evidence on new drugs and devices after approval.
Cipriani A, Ioannidis JPA, Rothwell PM, Glasziou P, Li T, Hernandez AF, Tomlinson A, Simes J, Naci H. Cipriani A, et al. Lancet. 2020 Mar 21;395(10228):998-1010. doi: 10.1016/S0140-6736(19)33177-0. Lancet. 2020. PMID: 32199487 Review.
Certain limitations of evidence available on drugs and devices at the time of market approval often persist in the post-marketing period. ...First, regulators (for drugs and devices), notified bodies (for devices in Europe), health …
Certain limitations of evidence available on drugs and devices at the time of market approval often persist in t …
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. Pease AM, et al. BMJ. 2017 May 3;357:j1680. doi: 10.1136/bmj.j1680. BMJ. 2017. PMID: 28468750 Free PMC article. Review.
Objective To characterize the prospective controlled clinical studies for all novel drugs that were initially approved by the Food and Drug Administration on the basis of limited evidence.Design Systematic review.Data sources Drugs@FDA database and Pub …
Objective To characterize the prospective controlled clinical studies for all novel drugs that were initially approved by the …
Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis.
McCormack PL. McCormack PL. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000. Drugs. 2012. PMID: 22397329 Review.
Tranexamic acid was generally well tolerated. Most adverse events in clinical trials were of mild or moderate severity; severe or serious events were rare. Therefore, while high-quality published evidence is limited for some approved indications, tranexamic a …
Tranexamic acid was generally well tolerated. Most adverse events in clinical trials were of mild or moderate severity; severe or ser …
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. Dhodapkar M, et al. JAMA Netw Open. 2021 Jun 1;4(6):e2113224. doi: 10.1001/jamanetworkopen.2021.13224. JAMA Netw Open. 2021. PMID: 34110392 Free PMC article.
IMPORTANCE: After US Food and Drug Administration (FDA) approval of a new drug, sponsors can submit additional clinical data to obtain supplemental approval for use for new indications. OBJECTIVE: To characterize pivotal trials supporting recent supple …
IMPORTANCE: After US Food and Drug Administration (FDA) approval of a new drug, sponsors can submit additional clinical data t …
Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.
Feldman MD, Petersen AJ, Karliner LS, Tice JA. Feldman MD, et al. J Gen Intern Med. 2008 Jan;23 Suppl 1(Suppl 1):57-63. doi: 10.1007/s11606-007-0275-4. J Gen Intern Med. 2008. PMID: 18095046 Free PMC article. Review.
INTRODUCTION: The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Alth …
INTRODUCTION: The global medical technology industry brings thousands of devices to market every year. However, significant gaps pers …
Digital aripiprazole or digital evergreening? A systematic review of the evidence and its dissemination in the scientific literature and in the media.
Cosgrove L, Cristea IA, Shaughnessy AF, Mintzes B, Naudet F. Cosgrove L, et al. BMJ Evid Based Med. 2019 Dec;24(6):231-238. doi: 10.1136/bmjebm-2019-111204. Epub 2019 Jul 18. BMJ Evid Based Med. 2019. PMID: 31320322
For the news reports, all languages were included if an English translation was available, and all records that were published after FDA approval were included. FINDINGS: In the primary evidence search, no RCT comparing digital aripiprazole with a non-digital …
For the news reports, all languages were included if an English translation was available, and all records that were published after FDA …
[The new approval process for the reimbursement of digital health applications (DiGA) from the perspective of the German statutory health insurance].
Gregor-Haack J, Busse T, Hagenmeyer EG. Gregor-Haack J, et al. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2021 Oct;64(10):1220-1227. doi: 10.1007/s00103-021-03401-1. Epub 2021 Aug 30. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2021. PMID: 34459939 Review. German.
At the same time, statutory health insurance identifies a number of basic and substantial critical issues regarding the legal requirements for the authorization of DiGA for reimbursement by insurance and the conceptional design of the fast-track process from the Federal Institute …
At the same time, statutory health insurance identifies a number of basic and substantial critical issues regarding the legal requirements f …
Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study.
Larochelle M, Downing NS, Ross JS, David FS. Larochelle M, et al. BMJ Open. 2017 Feb 8;7(2):e014582. doi: 10.1136/bmjopen-2016-014582. BMJ Open. 2017. PMID: 28179418 Free PMC article.
RESULTS: From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new
RESULTS: From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in …
The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Gupta R, Dhruva SS, Fox ER, Ross JS. Gupta R, et al. J Manag Care Spec Pharm. 2017 Oct;23(10):1066-1076. doi: 10.18553/jmcp.2017.23.10.1066. J Manag Care Spec Pharm. 2017. PMID: 28944731 Free PMC article.
Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. ...CONCLUSIONS: The UDI was associated with higher drug prices and more frequent drug shortages …
Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, no …
Internal support of tissue-engineered cartilage.
Arévalo-Silva CA, Eavey RD, Cao Y, Vacanti M, Weng Y, Vacanti CA. Arévalo-Silva CA, et al. Arch Otolaryngol Head Neck Surg. 2000 Dec;126(12):1448-52. doi: 10.1001/archotol.126.12.1448. Arch Otolaryngol Head Neck Surg. 2000. PMID: 11115280
The implants were harvested after 8 weeks of in vivo culture and histologically analyzed. RESULTS: Only implants coated by hydrogel plus cells generated healthy new cartilage. With 3 polymers (high-density polyethylene, acrylic, and extrapurified Silastic), the cove …
The implants were harvested after 8 weeks of in vivo culture and histologically analyzed. RESULTS: Only implants coated by hydrogel plus cel …
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