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

08:00 EDT 4th September 2019 | BioPortfolio

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

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.


Journal Details

This article was published in the following journal.

Name: JAMA network open
ISSN: 2574-3805
Pages: e1911111


DeepDyve research library

PubMed Articles [31597 Associated PubMed Articles listed on BioPortfolio]

Investigating Rates of Food and Drug Administration Approvals and Guidances in Drug Development: A Structural Breakpoint/Cointegration Timeseries Analysis.

The number of original and supplemental ANDAs, BLAs, NDAs, and Biosimilars FDA drug/biologic approvals (Approvals) has risen dramatically in the recent years, incidentally, so has the number of issued...

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

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 ...

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration.

An Evaluation of US Food and Drug Administration's Program to Register HIV Drugs for Use in Resource-Constrained Settings.

The US Food and Drug Administration (FDA) program to review antiretroviral drugs for use in low-resource settings via the US President's Emergency Plan for AIDS Relief (PEPFAR) now supports treatment ...

Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality.

Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when...

Clinical Trials [15367 Associated Clinical Trials listed on BioPortfolio]

Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according t...

Novel Diagnostics for Ocular Structure

The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT)....

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs

This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Clas...

A Study to Evaluate the Use of the Drug Combination Vorinostat, Niacinamide, and Etoposide in Patients With Lymphoid Malignancies That Have Reoccurred

The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medic...

Bioequivalence Study of Sodium Divalproate Tablets 500 mg

The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Admi...

Medical and Biotech [MESH] Definitions

An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.

The molecular designing of drugs for specific purposes (such as DNA-binding, enzyme inhibition, anti-cancer efficacy, etc.) based on knowledge of molecular properties such as activity of functional groups, molecular geometry, and electronic structure, and also on information cataloged on analogous molecules. Drug design is generally computer-assisted molecular modeling and does not include pharmacokinetics, dosage analysis, or drug administration analysis.

The use of multiple drugs administered to the same patient, most commonly seen in elderly patients. It includes also the administration of excessive medication. Since in the United States most drugs are dispensed as single-agent formulations, polypharmacy, though using many drugs administered to the same patient, must be differentiated from DRUG COMBINATIONS, single preparations containing two or more drugs as a fixed dose, and from DRUG THERAPY, COMBINATION, two or more drugs administered separately for a combined effect. (From Segen, Dictionary of Modern Medicine, 1992)

A standardized nomenclature for clinical drugs and drug delivery devices. It links its names to many of the drug vocabularies commonly used in pharmacy management.

Specific effects of drugs and substances on metabolic pathways such as those occurring through the CYTOCHROME P-450 ENZYME SYSTEM. These include effects that often result in DRUG INTERACTIONS; FOOD-DRUG INTERACTIONS; and HERB-DRUG INTERACTIONS.

Quick Search

DeepDyve research library

Relevant Topics

Clinical Approvals
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...

Searches Linking to this Article