Articles with "food drug" as a keyword



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Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads.

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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
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Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration.

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Published in 2019 at "JAMA internal medicine"

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
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Association Between Data Sources and US Food and Drug Administration Drug Safety Communications.

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Published in 2019 at "JAMA internal medicine"

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
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Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020

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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
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US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021.

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Published in 2023 at "JAMA internal medicine"

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
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Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs

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Published in 2018 at "JAMA Network Open"

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
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Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings

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Published in 2018 at "JAMA Network Open"

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;
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US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.

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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
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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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Published in 2019 at "JAMA Network Open"

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
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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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Published in 2019 at "JAMA Network Open"

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
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Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015

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Published in 2020 at "JAMA Network Open"

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