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Relevant bibliographies by topics / FDA Approval

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Academic literature on the topic 'FDA Approval'

Author: Grafiati

Published: 5 June 2025

Last updated: 2 August 2025

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Journal articles on the topic "FDA Approval"

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Khaki, Ali Raza, Aakash Desai, Martin W. Schoen, et al. "Timing of US Food and Drug Administration (FDA) cancer drug approvals relative to publication of clinical trial results." Journal of Clinical Oncology 38, no. 15_suppl (2020): 2071. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.2071.

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2071 Background: Publication of clinical trial results in peer reviewed literature is essential to inform clinicians regarding the use of new anti-cancer treatments, which often have a low therapeutic ratio and require careful assessment of risks and benefits. Publication of registration trials should precede FDA approval to facilitate evaluation and implementation of new therapies. The timing of trial publication relative to FDA drug approvals has not been systematically investigated. Methods: We collected all FDA drug approvals for a cancer indication between 2000-19. Trials were identified

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Mooghali, Maryam, Joshua D. Wallach, Joseph S. Ross, and Reshma Ramachandran. "Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies." JAMA Network Open 7, no. 8 (2024): e2430486. http://dx.doi.org/10.1001/jamanetworkopen.2024.30486.

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ImportanceThe US Food and Drug Administration (FDA) awards the breakthrough therapy designation to expedite development and review of therapeutics intended to treat serious conditions when preliminary clinical evidence demonstrates potential substantial improvement over existing therapies on clinically significant end points. Under the 21st Century Cures Act of 2016, the FDA is required to publish and routinely update a list of surrogate markers to provide industry sponsors with indication-specific information about end points that were or may be considered for approval. Therapeutics that are

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Lythgoe, Mark, Jonathan Krell, Jeremy Lyle Warner, Aakash Desai, and Ali Raza Khaki. "Time intervals between U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) new cancer therapy approvals." Journal of Clinical Oncology 39, no. 15_suppl (2021): 1575. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.1575.

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1575 Background: Novel therapies are transforming cancer care. Regulatory review and approval are essential to deliver safe and efficacious innovations to patients. Studies prior to 2010 describe quicker approval decisions for new oncology drug registrations with the FDA compared to the EMA (median delay 238 days). Both regulatory agencies have subsequently improved procedures to expedite approval times. We compared regulatory market authorisation dates at the FDA and EMA for new oncology therapies from 2010-2020. Methods: New oncology therapeutic approvals between 2010-2020 were identified fr

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Warner, Jeremy Lyle, Sanjay Mishra, Matthew James Hadfield, et al. "Who goes first? Patterns of cancer drug approvals across four major regulatory authorities: EMA, FDA, Health Canada, and PMDA." JCO Oncology Practice 19, no. 11_suppl (2023): 149. http://dx.doi.org/10.1200/op.2023.19.11_suppl.149.

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149 Background: New anticancer therapies have led to substantial improvements in prognosis across many cancers. Commercial access to a drug is not possible until the drug has received regional regulatory authority market authorization. In prior work (1), we found that European Medicines Agency (EMA) drug approvals frequently lagged US Food and Drug Administration (FDA) approvals from 2010-2019. Here, we expand the analytic time period to 2004-2023 and include two additional regulatory agencies – Health Canada (HC) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Methods: Drugs wi

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Carmagnani Pestana, Roberto, Douglas Dias e Silva, Bruna Bianca Lopes David, et al. "Sarcoma drug approvals in Latin America compared to the FDA and EMA: An analysis by the LACOG Sarcoma Group." Journal of Clinical Oncology 42, no. 16_suppl (2024): e13731-e13731. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e13731.

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e13731 Background: Drug approval processes by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) often shape regulatory decisions globally. This study describes the particularities of drug approval of systemic therapies for sarcomas by the FDA and EMA and compares them with those of three Latin American regulatory authorities: Brazil's ANVISA, Argentina's ANMAT, and Mexico's COFEPRIS. The aim is to elucidate the similarities and differences in approval practices, which may inform future regulatory strategies in these regions. Methods: We conducted a comprehensive

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Ouimet, Charlotte, Gauthier Bouche, and Jonathan Kimmelman. "Diminishing clinical impact for post-approval cancer clinical trials: A retrospective cohort study." PLOS ONE 17, no. 9 (2022): e0274115. http://dx.doi.org/10.1371/journal.pone.0274115.

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Background Once a drug gets FDA approved, researchers often attempt to discover new applications in different indications. The clinical impact of such post-approval activities is uncertain. We aimed to compare the clinical impact of research efforts started after approval with those started before for cancer drugs. Methods We used Drugs@FDA to perform a retrospective cohort study of secondary approvals for cancer drugs that were initially FDA approved between 2005 and 2017. Clinicaltrials.gov was used to identify the beginning of each research trajectory that resulted in a secondary FDA approv

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Shmela, Malak, and Mohaned Habbassi. "Overview in EMA and FDA Approved Novel Drugs in the Years 2020, 2021 and 2022." Libyan Journal of Medical Research 18, no. 1 (2024): 178–92. http://dx.doi.org/10.54361/ljmr18-1.18.

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Introduction: the drug approval is essential to any drugs to get in the market for use by patients. The current overview have been focuses on novel drugs approvals by European medicine agency (EMA) and food and drug administration (FDA).Objective: The researchers have been focused on the different between the EMA and FDA novel drugs approval during three years. Method: Throughout extracts the data from EMA and FDA and other sources and analyze the results like orphan drugs, dosage form, number of approvals, route of administration, pharmacotherapeutic class of novel drugs in both agencies.Resu

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Hirsh, Ryan, Justin Moyers, David Benjamin, and Hoda Pourhassan. "Evaluating Recent Drug Approvals for Hematologic Malignancies Utilizing the New European Society of Medical Oncology Magnitude of Clinical Benefit Scale for Hematology (ESMO-MCBS:H)." Blood 144, Supplement 1 (2024): 7638. https://doi.org/10.1182/blood-2024-208782.

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Introduction: Over the last decade, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have steadily leaned towards granting regulatory approval based on earlier phase trials and surrogate endpoints. Despite obtaining regulatory approval, many countries hold additional standards to assess the value of a new drug approval. The ESMO-MCBS is a tool created to evaluate the values and reduce bias or hype of drug approvals using various metrics: efficacy, quality of life, and duration of response. In 2023, the ESMO-MCBS:H was created for hematological malignancies. We

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Vadola, Lisa Ambrosini, Monique A. Pond, Ann Winter-Vann, and Robin Whitsell. "Faster approvals?: Trends in the use of FDA’s expedited approval programs for oncology medications." Journal of Clinical Oncology 35, no. 15_suppl (2017): e18270-e18270. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e18270.

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e18270 Background: With the importance of speed-to-market and addressing unmet needs, pharmaceutical companies have sought accelerated approvals through the Food and Drug Administration (FDA). Introduced with the FDA Safety and Innovation Act (FDASIA) of 2012, Breakthrough Therapy Designation (BTD) has become an important mechanism for approval of serious and life-threatening conditions that do not have adequate therapies. Notably, these pathways have been ill-understood by both pharmaceutical companies and health care providers. This study assessed how BTD and other FDA designations have play

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Marchi Blatt, Camila, Mario Henrique Furlanetto Miranda, Rafael Balsini Barreto, Bárbara Andressa Uliana, and Denize Bodnar. "Discrepancies in therapeutic indications for the same oncology drugs among FDA, EMA, and Brazilian agency." Journal of Clinical Oncology 42, no. 16_suppl (2024): e23035-e23035. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.e23035.

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e23035 Background: Divergent marketing approvals for oncology drugs among prominent agencies can prompt questions, especially when they are grounded in the same evidence. The aim of this study was to evaluate and compare the assessment and approval processes for novel products and indications by the FDA, EMA, and the Brazilian Health Regulatory Agency (ANVISA). Methods: Therapeutic indications for FDA-approved anticancer drugs from January 2019 to December 2023 were identified. Data, including approval dates, details on authorization procedures and evidence presented, were extracted from the d

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Dissertations / Theses on the topic "FDA Approval"

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Potthoff, Katharina. "FDA drug approval an analysis of the effects on stock prices /." St. Gallen, 2006. http://www.biblio.unisg.ch/org/biblio/edoc.nsf/wwwDisplayIdentifier/01665991002/$FILE/01665991002.pdf.

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Péladeau, Christine. "Utrophin A Upregulation by FDA-Approved Drugs for the Treatment of Duchenne Muscular Dystrophy." Thesis, Université d'Ottawa / University of Ottawa, 2019. http://hdl.handle.net/10393/39298.

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Duchenne Muscular Dystrophy (DMD) is a disorder caused by mutations in the dystrophin gene, preventing the production of the functional dystrophin protein which assures maintenance of the myofiber integrity throughout muscle contraction. A lack of dystrophin results in severe muscle degeneration and regeneration accompanied by a loss of muscle function. Many pre-clinical and clinical studies are focused on developing strategies to counteract the detrimental effects of DMD; however, there is no cure. One such approach consists of upregulating the endogenous protein utrophin A in dystrophic musc

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Witherspoon, Luke. "In Silico Mining of a System Wide Transcriptional Profiling Database for Clinically Relevant Gene Modulation by FDA Approved or FDA Ready Agents; Validation of a Novel Translational Approach." Thèse, Université d'Ottawa / University of Ottawa, 2011. http://hdl.handle.net/10393/20118.

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It has been recognized that small molecules can affect a substantial proportion of the human transcriptome in ways that are currently unknown and difficult to predict. Working with the Broad Institute, using their Connectivity Map database, we have worked to identify compounds anticipated to modulate two diseases; myotonic dystrophy (DM1) and Duchenne muscular dystrophy (DMD). DM1 stems from an expanded CTG repeat found in the DMPK gene. The down regulation of DMPK mRNA represents a valid therapeutic avenue. DMD is characterized by degeneration of muscle, caused by mutations in the dystrophin

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Johnstone, Andrea. "Overcoming Glial-Derived Inhibition of Regeneration in CNS Neurons: From Novel Compounds to Novel Uses for FDA-Approved Compounds." Scholarly Repository, 2011. http://scholarlyrepository.miami.edu/oa_dissertations/631.

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Trauma to the central nervous system (CNS) results in an irreversible disruption of axon tracts, often leading to lifelong functional deficits. Despite a large body of research into the mechanisms that underlie the lack of axonal regeneration after CNS injury, there are currently no effective treatments. One major obstacle involves the presence at injury sites of CNS growth-inhibitory molecules, such as myelin proteins and astrocyte-derived chondroitin sulfate proteoglycans (CSPGs), which act as environmental barriers to axonal regeneration. Our lab recently described the identification and

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Alqahtani, Saad Mohammed S. "Molecular Determinants for Binding of the FDA-Approved Drugs in Proteins – A Data Mining and Advanced Quantum Chemical Study." University of Toledo / OhioLINK, 2017. http://rave.ohiolink.edu/etdc/view?acc_num=toledo1493378726116385.

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MASSARO, DAMIANO SERGIO. "Drug Reprofile for Friedreich’s Ataxia: Screening of an FDA-Approved Drugs Library searching for small molecules that increase Frataxin." Doctoral thesis, Università degli Studi di Roma "Tor Vergata", 2015. http://hdl.handle.net/2108/203080.

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Freidreich’s Ataxia (FRDA) is a neurodegenerative, autosomal hereditary disease characterized by progressive neurodegeneration, cardiomyopathy and increased incidence of diabetes. The disease is caused by a trinucleotide GAA repeat expansion within the first intron of the gene coding for frataxin protein (FXN). Pathological GAA expansion (from ~70 to >1,000 triplets) results in “sticky” DNA structures and epigenetic changes that severely reduce transcription of the gene. FRDA patients live with 10-30% residual frataxin. The severity of the disease is proportionally related to the number of

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Capua, Christopher James. "Comparative Cytotoxicity of an FDA-approved Cancer Drug to Extracts of Atriplex confertifolia on Human Breast and Cervical Cancer Cells." BYU ScholarsArchive, 2008. https://scholarsarchive.byu.edu/etd/1703.

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The severity and number of people affected by cancer is a worldwide problem with millions of people affected annually. The search for treatment and cures of cancer continues to be a global effort. As part of this global effort, many natural products have been tested against cancer cell lines, most from plants located in tropical regions. However, this study reports that extracts of Atriplex confertifolia, a native North American plant, has significant bioactivity against human breast cancer cell lines MCF-7, 435, and 231, and HeLa cells (cervical cancer cells). The bioactivity of A. confertifo

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Chen, Po Chang, and 陳柏昌. "The Impact of FDA New Drug Approval on Abnormal Return of Nasdaq Biotech Stock." Thesis, 2009. http://ndltd.ncl.edu.tw/handle/64978819916415095797.

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碩士<br>長庚大學<br>企業管理研究所<br>97<br>We observe two kinds of stocks. One is the components of Nasdaq Biotechnology Index (hereafter, cNBI) and the other is components of Phlx Drug Index (hereafter, cRXS). This study use an event study methodology for calculating abnormal return (hereafter, AR) and cumulative abnormal return (hereafter, CAR) in the condition of FDA new drugs approvals. We use t-test to check whether AR differ from zero and use multiple regression model to examine whether some variables have influences in AR. We have three findings. First, AR of cNBI is significantly higher than zero,

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Ting, Hsiu Wen, and 丁秀文. "Announcement Effect of Drug Approvals by FDA." Thesis, 2008. http://ndltd.ncl.edu.tw/handle/47956984302631612365.

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碩士<br>國立政治大學<br>財務管理研究所<br>96<br>In this paper, we use event-study to estimate the stock price changes of Food and Drug Administration (FDA) decisions on new products for pharmaceutical companies. We find that FDA decisions have insignificant effects in all countries on the drug approval date. The insignificant price changes accompanying FDA announcements approval suggest that drug results have leaked to the market. It is quite possible that the results of advisory are open to public and advisory committee are held before FDA approval, advisory committee can be viewed as important news source

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Chang, En-Kai, and 張恩愷. "Combinatorial effects of six FDA approved drugs on influenza virus." Thesis, 2018. http://ndltd.ncl.edu.tw/handle/3272nt.

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碩士<br>國立陽明大學<br>微生物及免疫學研究所<br>106<br>英文摘要 Influenza virus belongs to Orthomyxoviridae. Influenza spreads around the world yearly, resulting in about three to five million cases of severe illness and about 250,000 to 500,000 deaths. The only drugs currently available to treat influenza are neuraminidase ( NA ) inhibitors,including oseltamivir ( Tamiflu ), zanamivir and peramivir, and an RNA-dependent RNA polymerase ( RdRp ) inhibitor, favipiravir ( Avigan ). Since influenza virus RdRp lacks proofreading activity, the genome is easy to mutate when replicating. As a result, drug resistance and li

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Books on the topic "FDA Approval"

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Center for Drug Evaluation and Research (U.S.), ed. Drugs@FDA. U.S. Food and Drug Administration, Center for Drug and Evaluation Research, 2004.

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D, Hynes Martin, ed. Preparing for FDA pre-approval inspections. Marcel Dekker, 1999.

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Beers, Donald O. Generic drugs: A guide to FDA approval requirements. Prentice Hall Law & Business, 1988.

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Beers, Donald O. Generic drugs: A guide to FDA approval requirements. 2nd ed. Prentice Hall Law & Business, 1989.

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Hawthorne, Fran. Inside the FDA. John Wiley & Sons, Ltd., 2005.

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D, Greenberg Michael. AIDS, experimental drug approval, and the FDA new drug screening process: A legal research guide. W.S. Hein & Co., 1999.

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Association, Health Industry Manufacturers, United States. Food and Drug Administration., Biometric Research Institute, and Device Submissions Workshop (1991 : Arlington, Va.), eds. Medical device submissions handbook: A guide to obtaining FDA approval. HIMA, 1991.

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O, Beers Donald, ed. Generic and innovator drugs: A guide to FDA approval requirements. 3rd ed. Prentice Hall Law & Business, 1992.

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Office, General Accounting. FDA drug approval: Review time has decreased in recent years : report to Congressional requesters. The Office, 1995.

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Sasinowski, Frank J. Drug and biologic approvals: The complete guide for small business : FDA financial assistance and incentives. FDLI, 2000.

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Book chapters on the topic "FDA Approval"

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Basu, Sankar. "Requirements for FDA Approval." In Lecture Notes in Electrical Engineering. Springer US, 2008. http://dx.doi.org/10.1007/978-0-387-71809-5_25.

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Burgess, Cathy L., Justin Mann, and Seth Olson. "FDA Pre-approval Inspections." In Good Manufacturing Practices for Pharmaceuticals. CRC Press, 2019. http://dx.doi.org/10.1201/9781315120669-22.

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Walter, Megan, and Lindsay E. Wagner. "FDA and Drug Approval Process." In O'Donnell's Drug Injury, 5th ed. CRC Press, 2025. https://doi.org/10.1201/9781003615323-2.

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Eaglstein, William H. "The FDA Approval Process and Drug Development." In The FDA for Doctors. Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-08362-9_10.

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Ning, Yang-Min, Ramzi N. Dagher, and Richard Pazdur. "FDA Approval of Prostate Cancer Treatments." In Drug Management of Prostate Cancer. Springer New York, 2010. http://dx.doi.org/10.1007/978-1-60327-829-4_35.

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Negowetti, Nicole E. "Textbox: FDA Approval of GE Salmon." In International Farm Animal, Wildlife and Food Safety Law. Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-18002-1_15.

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Lowenthal, Richard E., and Robert G. Bell. "Changes in Biologic Drug Approval at FDA." In Biopharmaceutical Drug Design and Development. Humana Press, 2008. http://dx.doi.org/10.1007/978-1-59745-532-9_15.

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Greenberg, Michael L. "Enfuvirtide: from basic science to FDA approval." In Entry Inhibitors in HIV Therapy. Birkhäuser Basel, 2007. http://dx.doi.org/10.1007/978-3-7643-7783-0_11.

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Roshmi, Rohini Roy, and Toshifumi Yokota. "Viltolarsen: From Preclinical Studies to FDA Approval." In Methods in Molecular Biology. Springer US, 2022. http://dx.doi.org/10.1007/978-1-0716-2772-3_2.

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Froehlich, Jacob Michael, Alice Ignaszewski, and Anna O’Brien. "The FDA New Animal Drug Approval Process." In Learning from Disease in Pets. CRC Press, 2020. http://dx.doi.org/10.1201/9780429056178-10.

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Conference papers on the topic "FDA Approval"

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Crovetto, Rosa, and Eunice Murtagh. "Novel Boiler Condensate Corrosion Inhibitor with FDA Approval." In CORROSION 2007. NACE International, 2007. https://doi.org/10.5006/c2007-07073.

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Abstract Oxygen pitting corrosion and general acid corrosion have historically been problems in food processing facilities. This is true where the steam contacts the food being produced due to the limitations on the condensate corrosion inhibitor dose imposed by the FDA. This paper presents performance data regarding a novel condensate corrosion inhibitor that provides improved corrosion protection versus several existing FDA-approved commercial filming inhibitors. This new inhibitor is designed to be fed to the steam phase to protect iron and copper alloys in the steam condensate system again

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Beman, Roger. "Design, Fabrication, and Erection of a 350,000 Gallon Fiberglass Potable Water Tank Meeting FDA Requirements." In CORROSION 2005. NACE International, 2005. https://doi.org/10.5006/c2005-05506.

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Abstract Storage of potable water for high volume production is a concern throughout the food and beverage industry. Care must be taken to avoid contamination, and shutting vessels down for maintenance is costly both as a maintenance item as well as for the cost of the loss of production. Even the inspection of process vessels requires taking the vessel out of service, then decontaminating the vessel again prior to putting it back on line. The use of materials that will not rust, do not require additional surface coatings, and that are FDA approved throughout the vessel wall for food and bever

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Hannan, Md Nafiz, and Timothy M. Baran. "Development of a Single-fiber Spectroscopy System using Unmodified Clinical Laser Fibers for Tissue Optical Property Recovery." In Clinical and Translational Biophotonics. Optica Publishing Group, 2025. https://doi.org/10.1364/translational.2025.tm3f.5.

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We developed a simple single-fiber spectroscopy system using an unmodified FDA-approved laser fiber. Preliminary optical property recovery with a semi-empirical model showed promise but requires further optimization for clinical implementation.

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Jacobs, Paula M. "Overview of FDA approval paths optical surgical navigation." In SPIE BiOS, edited by Brian W. Pogue and Sylvain Gioux. SPIE, 2017. http://dx.doi.org/10.1117/12.2257152.

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Kice, Richard, Nick Schaaf, David Broadwater, et al. "Manufacturing and approval requirement differences between FDA/CDRH and the DoD." In ILSC® 2011: Proceedings of the International Laser Safety Conference. Laser Institute of America, 2011. http://dx.doi.org/10.2351/1.5056742.

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Marcus, Stuart. "Tom Dougherty and the FDA approval of PDT photosensitizers (Conference Presentation)." In 17th International Photodynamic Association World Congress, edited by Tayyaba Hasan. SPIE, 2019. http://dx.doi.org/10.1117/12.2541578.

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Webster, Thomas J. "Creating Nanostructured Coatings to Improve Medical Performance While Obtaining Fast FDA Approval." In Annual Technical Conference Proceedings. Society of Vacuum Coaters, 2018. http://dx.doi.org/10.14332/svc17.proc.43094.

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Abdul, Kulsoom. "NATALEE: Success with adjuvant ribociclib leads to FDA approval in early breast cancer." In San Antonio Breast Cancer Symposium 2024, edited by Stefan Rauh. Medicom Medical Publishers, 2025. https://doi.org/10.55788/1c85f9f1.

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Hwang, Wonjun, Pooja Singhal, and Duncan J. Maitland. "Estimation of the Stresses Applied on Aneurysm Wall by the Expansion of Shape Memory Polymer Foam." In ASME 2010 Summer Bioengineering Conference. American Society of Mechanical Engineers, 2010. http://dx.doi.org/10.1115/sbc2010-19637.

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SMP foams have been proposed for an improved treatment of aneurysms over the currently used Guglielmi Detachable Coils (GDC) [1]. With the recent FDA approval of first SMP medical device in March 2009 by FDA, this procedure has a high potential of being used in aneurysm treatment in humans [2].

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Nilsen, Birgir. "Type Approval for UV based system, USGC vs IMO." In IMarEST Ballast Water Technology Conference. IMarEST, 2017. http://dx.doi.org/10.24868/bwtc6.2017.002.

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Optimarin AS, a pioneer in ballast water treatment, has become the first system supplier to receive the USCG Type Approval (TA) Letter meeting the most stringent US Coast Guard test requirements. In a series of land-based tests, both the standard Most Probable Number (MPN) (regrowth) method and the more exacting technique known as FDA/CMFDA, or ‘instant kill’, benchmark was successfully assessed. Testing of the Optimarin system was carried out by DNV GL at the Norwegian Institute of Water Reseearch (NIVA) test facility in Norway. The system was also tested in parallel on a bulk carrier trading

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Reports on the topic "FDA Approval"

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Berndt, Ernst, Adrian H. Gottschalk, Tomas Philipson, and Matthew Strobeck. Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process. National Bureau of Economic Research, 2004. http://dx.doi.org/10.3386/w10822.

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Holmes, Rebecca, Keeley Blackie, Ilya Ivlev, and Erick H. Turner. Enhancing Systematic Review Methods by Incorporating Unpublished Drug Trials. Agency for Healthcare Research and Quality (AHRQ), 2025. https://doi.org/10.23970/ahrqepcwhitepaperenhancing.

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Systematic reviews often omit unpublished data due to time constraints, unclear data integration methodologies, and uncertainties about the value of including these data. This can lead to inflated efficacy estimates and underestimated harms or burdens, as unpublished studies often document negative efficacy outcomes and/or harms. This brief methods project demonstrated the integration of U.S. Food and Drug Administration (FDA) drug approval packages (i.e., FDA reviews) into three systematic reviews focusing on psychoactive drugs—paroxetine (Paxil®) for adults with post-traumatic stress disorde

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Lipton, Stuart A. Application of FDA-Approved Memantine and Newer NitroMemantine Derivatives to Treat Neurological Manifestations in Rodent Models of Tuberous Sclerosis Complex. Defense Technical Information Center, 2014. http://dx.doi.org/10.21236/ada604193.

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Moffitt, Christine A. FDA Approved Registration of Erythromycin for Treatment of Bacterial Kidney Disease (BKD) in Juvenile and Adult Chinook Salmon : Annual Report, Reporting Period March 10, 1989 to March 9, 1990. Office of Scientific and Technical Information (OSTI), 1991. http://dx.doi.org/10.2172/5392957.

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Research, IFF. FSA and Official Controls: Research with Food Business Operators. Food Standards Agency, 2023. http://dx.doi.org/10.46756/sci.fsa.drn484.

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The Food Standards Agency (FSA) is an independent Government body, established in 2000 to protect public health and consumer interests in relation to food. The FSA is the Central Competent Authority (CCA) responsible for the delivery of official food and feed controls in England, Northern Ireland and Wales.. In Northern Ireland, officials from the Department of Agriculture, Environment and Rural Affairs (DAERA) carry out meat hygiene official controls in approved establishments on behalf of the FSA. Food Business Operators (FBOs) in the dairy, meat and wine sectors have a direct relationship w

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Sulaiman, Abdulgafar, Uthman Mohamed Ali, and Imad Al-Qadi. Evaluation of the Asphalt Mixture Design Framework for Airfield Pavements in Illinois. Illinois Center for Transportation, 2023. http://dx.doi.org/10.36501/0197-9191/23-011.

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The Federal Aviation Administration (FAA) advisory circular AC 150/5100-13 authorized the use of state highway material specifications at nonprimary public-use airports serving aircraft less than 60,000 pounds gross weight. This approval is based on the condition that the safety and life span of these airports will not be adversely affected. The use of highway materials provides the Illinois Department of Transportation (IDOT) with benefits, including cost, expertise, material availability, and sustainability. This study investigated the feasibility of using highway mixes for nonprimary airpor

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Matthews, Lisa, Guanming Wu, Robin Haw, et al. Illuminating Dark Proteins using Reactome Pathways. Reactome, 2022. http://dx.doi.org/10.3180/poster/20221027matthews.

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Diseases are often the consequence of proteins or protein complexes that are non-functional or that function improperly. An active area of research has focused on the identification of molecules that can interact with defective proteins and restore their function. While 22% percent of human proteins are estimated to be druggable, less than fifteen percent are targeted by FDA-approved drugs, and the vast majority of untargeted proteins are understudied or so-called "dark" proteins. Elucidation of the function of these dark proteins, particularly those in commonly drug-targeted protein families,

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Calabretta, Emily. Increasing respiratory syncytial virus vaccination rates through a provider education program : a quality improvement project. University of Missouri - Columbia, 2024. https://doi.org/10.32469/10355/106501.

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Respiratory Syncytial Virus (RSV) primarily affects the lower respiratory tract and can lead to severe respiratory illness, particularly in older adults and those with compromised immune systems. Currently, there is no cure for RSV; hence, prevention through vaccination is critical. The Food and Drug Administration (FDA) has approved single-dose vaccines for adults aged 60 years and older, recommended for administration prior to the RSV season. Methods. This quality improvement (QI) project aimed to assess the impact of an RSV vaccine informational session tailored to primary care providers on

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Yoel, David, Tina Sicilia, Matthew Bogaart, and Jeremy Fernandes. PR-417-203902-R01 Remote Sensing and Leak Detection Platform That Can Deploy Multiple Sensor Types. Pipeline Research Council International, Inc. (PRCI), 2024. http://dx.doi.org/10.55274/r0000052.

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The PRCI Project #417-203902 - ROW 3-1-A Final Report is attached for Member review and comment. The report includes a summary of all work completed in all Tasks which include: - Catalog, taxonomy, and sample data set for the threats detected. - Benchmarks of the sensitivity, accuracy, reliability, and robustness of an automated multi sensor, multi-threat detection and near real-time reporting comparing performance on conventional aircraft and UAS. - Technical synopsis for operators on integrating automated near real-time aerial threat reports into pipeline performance and safety improvement p

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Jorgensen, Frieda, Andre Charlett, Craig Swift, Anais Painset, and Nicolae Corcionivoschi. A survey of the levels of Campylobacter spp. contamination and prevalence of selected antimicrobial resistance determinants in fresh whole UK-produced chilled chickens at retail sale (non-major retailers). Food Standards Agency, 2021. http://dx.doi.org/10.46756/sci.fsa.xls618.

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Campylobacter spp. are the most common bacterial cause of foodborne illness in the UK, with chicken considered to be the most important vehicle for this organism. The UK Food Standards Agency (FSA) agreed with industry to reduce Campylobacter spp. contamination in raw chicken and issued a target to reduce the prevalence of the most contaminated chickens (those with more than 1000 cfu per g chicken neck skin) to below 10 % at the end of the slaughter process, initially by 2016. To help monitor progress, a series of UK-wide surveys were undertaken to determine the levels of Campylobacter spp. on

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