Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads.
Sign Up to like & getrecommendations! Published in 2017 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2016.7151
Abstract: Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with adequate and well-controlled clinical trials, a drug’s safety and efficacy for each intended use and has prohibited the “offlabel” promotion… read more here.
Keywords: court; evidence; drug; food drug ... See more keywords
Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration.
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DOI: 10.1001/jamainternmed.2019.1213
Abstract: This cross-sectional study reviews New Drug Applications for new molecular entities and Biologics License Applications for new and biosimilar biological products submitted to the US Food and Drug Administration to assess how frequently applicants disclose… read more here.
Keywords: drug; drug administration; food drug; new drug ... See more keywords
Association Between Data Sources and US Food and Drug Administration Drug Safety Communications.
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DOI: 10.1001/jamainternmed.2019.3066
Abstract: Association Between Data Sources and US Food and Drug Administration Drug Safety Communications Drug safety communications (DSCs) are the primary tool for the US Food and Drug Administration (FDA) to communicate important new postmarketing safety… read more here.
Keywords: safety communications; safety; drug administration; drug ... See more keywords
Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020
Sign Up to like & getrecommendations! Published in 2022 at "JAMA Internal Medicine"
DOI: 10.1001/jamainternmed.2022.4924
Abstract: This cross-sectional study estimates all US Food and Drug Administration anticancer approvals in recent years and evaluates if an association exists between their cost and efficacy. read more here.
Keywords: food drug; oncology; drug administration; drug ... See more keywords
US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021.
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DOI: 10.1001/jamainternmed.2022.6444
Abstract: This cross-sectional study determines the frequency of and rationale for US Food and Drug Administration (FDA) approval of drugs not meeting pivotal trial primary efficacy end points. read more here.
Keywords: drugs meeting; meeting pivotal; food drug; drug administration ... See more keywords
Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
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DOI: 10.1001/jamanetworkopen.2018.0283
Abstract: Key Points Question What is the timing and duration of investigational drug availability through the US Food and Drug Administration’s (FDA’s) expanded access program? Findings In this cross-sectional study of 92 FDA-approved drugs with associated… read more here.
Keywords: investigational medicines; drug administration; food drug; access ... See more keywords
Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings
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DOI: 10.1001/jamanetworkopen.2018.3337
Abstract: Key Points Question What are the trends across adulterated dietary supplements associated with a warning released by the US Food and Drug Administration from 2007 through 2016? Findings In this quality improvement study, analysis of… read more here.
Keywords: drug administration; dietary supplements; food drug;
US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA network open"
DOI: 10.1001/jamanetworkopen.2019.11111
Abstract: Importance The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown. Objectives To… read more here.
Keywords: drug administration; drug; clinical trials; food drug ... See more keywords
Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
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DOI: 10.1001/jamanetworkopen.2019.3410
Abstract: This cross-sectional study characterizes postapproval clinical trials sponsored by pharmaceutical companies of therapeutics approved by the US Food and Drug Administration (FDA) without postmarketing requirements or commitments. read more here.
Keywords: postapproval clinical; drug administration; clinical trials; food drug ... See more keywords
Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration’s Adverse Event Reporting System, 2010-2017
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DOI: 10.1001/jamanetworkopen.2019.9249
Abstract: Key Points Question What is the postmarketing safety profile of sipuleucel-T in the United States? Findings The US Food and Drug Administration’s Adverse Event Reporting System received 3216 reports for sipuleucel-T from 2010 through 2017.… read more here.
Keywords: reporting; administration adverse; adverse event; drug administration ... See more keywords
Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015
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DOI: 10.1001/jamanetworkopen.2020.9498
Abstract: This cross-sectional study examines the frequency of disagreements within the US Food and Drug Administration (FDA) regarding approval of novel therapeutic agents. read more here.
Keywords: approval novel; regarding approval; disagreements within; drug administration ... See more keywords