Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 20 of 697 for “"FDA"”.
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Demographic profiles of clinical research participants in FDA-approved NMEs
… approved by the U.S. Food Drug Administration (FDA) for 2010 and 2020 to compare demographic representation. Demographic representation of trial participants for 61 FDA-approved NMEs for 2010 and 2020 were gathered; 21 NMEs were excluded from analysis. The trends in demographic representation in …
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Factors influencing FDA clearance time for medical device 510(k)
Since the FDA Modernization Act of 1997, recent legislation has sought to establish performance goals and consistency in the regulatory review and clearance of new medical devices. Despite these goals, regulatory review times have varied dramatically for devices seeking clearance through the 510(k) …
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Factors influencing the time for FDA review of medical devices
… by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application (PMA) is the process by which this occurs. Companies submit a PMA after they have completed laboratory test, …
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An evaluation and comparison of current FDA-approved treatments for obesity
… phentermine/ topiramate extended-release became FDA-approved for long-term treatment of obesity. Each drug acts on a specific part of the CNS to modulate appetite and cause decreased food intake in patients. Clinical trials conducted on these medications found phentermine/topiramate …
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Investigating FDA-Approved Drugs for Treatment of Multidrug-Resistant Neisseria gonorrhoeae
… is a promising approach. In this study, an FDA-approved drug library was screened, and 14 drugs were found to exhibit promising anti-gonococcal activity. Interestingly, three extremely potent and narrow-spectrum novel candidates, itraconazole, isavuconazole, and ravuconazole, are azole …
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Implementation of the new FDA quality by design guidance in pharmaceutical production
… to the growing need for improvement, the FDA issued a guidance to industry that provides a framework for acquiring improved process understanding and product quality in the manufacturing industry. The guidance is aimed at encouraging the use of process analytical technology (PAT) to …
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A method for analysis of expert committee decision-making applied to FDA medical device panels
… of this method to a set of 37 meetings from the FDA's Circulatory Systems Devices Panel shows the presence of numerous effects. Prominent among these is the propensity for panel members from similar medical specialties to use similar language. Furthermore, panel members who use similar language …
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An Investigation of the FDA (Failure to Do Assignment) Program in Helping Middle School Students Complete School Assignments
… of the Failure to Do Assignment System (FDA) were examined as to their impact in helping middle school students complete school assignments. Procedure: Survey data was collected from the ninety-two sixth, seventh, and eighth grade students at the Newell-Fonda Middle School. A …
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Policy analysis of foreign trials needed for FDA-approved INDs for devices and drugs from 2016 to 2020
… were taken from clinicaltrials.gov and the FDA’s website from the years 2016 to 2020 to show the relationship of medical devices approved without the use of multinational data compared to drugs. Although there were more medical devices approved by the FDA without the use of foreign data, the …
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A study of the challenges faced by FDA-regulated early-stage medical device startups and how to approach them
… the United States Food and Drug Administrations (FDA). This thesis explores the difficulties faced by startups and proposes a step-by-step guide for the founders to navigate this challenge. The guide seeks information from the regulations database, and from interviews with stakeholders involved in …
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Pharmacological inhibition of CK2: the effect of an FDA designated orphan drug on pathology, neuroinflammation, and glial phenotypes in Huntington’s disease
… neuronal function. Silmitasertib (CX-4945) is an FDA designated orphan drug that inhibits CK2. This study aims to investigate whether CX-4945 treatment ameliorates HD pathology. We treated prodromal and late symptomatic HD mice, and used a variety of immunohistochemical, biochemical, physiological …
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Improving the efficiency of the later stages of the drug development process : survey results from the industry, academia, and the FDA
… I, which mandated faster response times from the FDA in return for user fee payments to the FDA by the drug developing companies. Data on approval times for new drugs indicate that this process was indeed shortened. In contrast, the average drug development process prior to the filing of an …
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Cell wall metabolite levels as a function of the growth phase in Staphylococcus aureus and library screening for synergistic combinations of FDA approved drugs against methicillin resistant S. aureus
… we performed a high-throughput screening of FDA-approved compounds in the presence and absence of ceftobiprole, identifying intrinsically active agents and synergistic combinations with ceftobiprole. A checkerboard analysis was then performed on potential ceftobiprole synergistic agents. …
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Renal Toxicity Warnings and Precautions of Drugs Marketed in the US
… This study assessed the characteristics of FDA renal toxicity warnings and precautions included in the labels of drugs approved by the FDA and marked in the US. The study also evaluated the potential factors of including a boxed warning on a drug label.</p> <p>METHODS: We extracted the …
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Studium toxicity PFAS s využitím řas
… using the growth inhibition test and the FDA test. These tests were chosen to determine whether the FDA test could be used as an alternative growth inhibition test to test the toxicity of PFAS on P. subcapita. In the standardized growth inhibition assay, the chlorophyll fluorescence signal …
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Regulatory issues concerning the preclinical testing of synthetic peptides
… the United States Food and Drug Administration (FDA) before it becomes available for human use. A sponsor files an investigational new drug (IND) application with the FDA with supporting animal data, after which testing is continued with humans. There is sufficient guidance from the FDA on new …
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Approvals, Utilization, and Cost of Biologics for the Treatment of Rheumatoid Arthritis
… RA patient population. It also identified the FDA approval status of bDMARDs and assessed the annual cost of bDMARDs used in RA treatment, evaluated the factors explaining annual cost at market entry.</p> <p><strong>Methods: </strong>In the retrospective analysis of Medical Expenditure Panel …
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An Economic and Regulatory Analysis of Breast Cancer Drugs Approved by the US Food and Drug Administration
… of breast cancer. This study assessed trends in FDA approvals and prices at the market entry of new drugs indicated for breast cancer in the period 1980-2022. The study also evaluated the factors associated with the price of the new breast cancer drugs at market entry.</p> <p><strong>Material and …
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Orphan Drugs: Designations, Approvals, and Prices in the US
… the treatment cost of new drugs approved by the FDA from 2017 to 2021.</p> <p><strong>Material and Methods.</strong> We collected data for orphan drugs approved in the US from 1983 to 2021 from the FDA online databases Drugs@FDA and Orphan Drug Product Designations and Approvals. The wholesale …
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