LAUSR

Association Between Gender and Drug Cost for Over-the-Counter Minoxidil

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0 Published in 2017 at "JAMA Dermatology"

DOI: 10.1001/jamadermatol.2017.1394

Abstract: Association Between Gender and Drug Cost for Over-the-Counter Minoxidil Minoxidil is a US Food and Drug Administration (FDA)– approved over-the-counter topical medication for androgenetic alopecia marketed and sold to men and women. Approximately 50 million… read more here.

Keywords: minoxidil; drug cost; cost counter; gender drug ... See more keywords

Dupilumab Drug Survival and Associated Predictors in Patients With Moderate to Severe Atopic Dermatitis: Long-term Results From the Daily Practice BioDay Registry.

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1 Published in 2022 at "JAMA dermatology"

DOI: 10.1001/jamadermatol.2022.3014

Abstract: Importance Long-term data on dupilumab drug survival in patients with atopic dermatitis (AD) are scarce. Furthermore, little is known about the factors associated with drug survival of dupilumab in AD. Objective To describe the drug… read more here.

Keywords: year; drug survival; bioday registry; dupilumab drug ... See more keywords

Evidence-Based Clinical Practice Guidelines for Laser-Assisted Drug Delivery.

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1 Published in 2022 at "JAMA dermatology"

DOI: 10.1001/jamadermatol.2022.3234

Abstract: Importance Laser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD. Objective To develop recommendations for the safe and effective use of… read more here.

Keywords: review; drug; drug delivery; evidence based ... See more keywords

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

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1 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

Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016

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2 Published in 2018 at "JAMA Internal Medicine"

DOI: 10.1001/jamainternmed.2018.3931

Abstract: Importance A critical question in health care is the extent of scientific evidence that should be required to establish that a new therapeutic agent has benefits that outweigh its risks. Estimating the costs of this… read more here.

Keywords: trial; drug; million million; 2015 2016 ... See more keywords

An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.

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1 Published in 2019 at "JAMA internal medicine"

DOI: 10.1001/jamainternmed.2019.0583

Abstract: Importance Approximately one-third of cancer drugs are approved based on response rate (RR)-the percentage of patients whose tumors shrink beyond an arbitrary threshold-typically assessed in a single-arm study. Objective To characterize RR end points used… read more here.

Keywords: cancer drugs; response; drug; rate ... 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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1 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

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

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0 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

US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.

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1 Published in 2019 at "JAMA internal medicine"

DOI: 10.1001/jamainternmed.2019.5451

Abstract: Importance Regulatory and scientific guidelines stipulate that indirect, surrogate measures of patient benefit, such as a change in microbial culture status, should be used as primary end points only in pivotal trials of chronic conditions… read more here.

Keywords: primary end; end points; surrogate measures; anti infective ... See more keywords

Policy Implications of the Orphan Drug Designation for Remdesivir to Treat COVID-19.

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1 Published in 2020 at "JAMA internal medicine"

DOI: 10.1001/jamainternmed.2020.2759

Abstract: On March 23, 2020, the US Food and Drug Administration (FDA) granted Gilead Science an orphan drug designation for remdesivir to treat coronavirus disease 2019 (COVID-19), even though this status is usually reserved for drugs… read more here.

Keywords: drug; drug designation; orphan drug; designation remdesivir ... 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

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2 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