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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 …
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.
This article reviews the efficacy and tolerability of tranexamic acid in conditions amenable to antifibrinolytic therapy and briefly overviews the pharmacological properties of the drug. In large, randomized controlled trials, tranexamic acid generally significantly …
This article reviews the efficacy and tolerability of tranexamic acid in conditions amenable to antifibrinolytic therapy and briefly overvie …
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
BACKGROUND: In November 2017, the Food and Drug Administration (FDA) approved a version of a second-generation antipsychotic, aripiprazole, embedded with a sensor (Abilify MyCite). OBJECTIVE: To systematically review the evidence supporting the FDA' …
BACKGROUND: In November 2017, the Food and Drug Administration (FDA) approved a version of a second-generation antipsyc …
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 …
IMPORTANCE: After US Food and Drug Administration (FDA) approval of a new drug, sponsors can submit additional c …
[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.
DESIGN: A cohort study. SETTING: New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. ...Of the 110 new drugs approved in Europe and/or Canada bef …
DESIGN: A cohort study. SETTING: New therapeutics approved by the Food and Drug Administration (FDA), European Medicine …
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 …
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.
The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. ...CONCLUSIONS: The UDI was associated with higher drug pric …
The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA …
Internet-based device-assisted remote monitoring of cardiovascular implantable electronic devices: an evidence-based analysis.
Pron G, Ieraci L, Kaulback K; Medical Advisory Secretariat, Health Quality Ontario. Pron G, et al. Ont Health Technol Assess Ser. 2012;12(1):1-86. Epub 2012 Jan 1. Ont Health Technol Assess Ser. 2012. PMID: 23074419 Free PMC article. Review.
An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer's devices. ...RESEARCH QUESTIONS: The research directions and specific research questions for this evidence review were as fo …
An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer's …