In addition, you may wish to search theClinicalTrials.gov website(a service of the U.S. National Institutes of Health) for studies involving ivermectin and/or hydroxychloroquine and COVID-19. It is intended to be a central resource, providing current information on clinical trials to patients,...
The US Food and Drug Administration (FDA) will soon require researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants.Access options Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value ...
* More information on the FDA Phase I trial of these combined compounds can be found at:http://www.clinicaltrials.gov/ct2/show/NCT00603863?term=Immunomedics LEGAL DISCLAIMER This website it not affiliated with nor sponsored by Immunomedics, Inc. (“IMMU”) or any of its officers, directors,...
The U.S National Library of Medicine ClinicalTrials.gov website serves as a resource for identifying devices that are currently under investigation prior to FDA authorization. For example, the ClinicalTrials.gov website lists several investigations on the use of accelerated TMS for suicidal ideation ...
More from Clinical Trials ‘Fear And Anxiety’ As Rare Disease Community Confronts US Government Actions 07 Feb 2025 •BySue Sutter The sudden halt to grants and health agency communications is causing stress for the rare disease advocacy community, speakers said at a recent rare dis...
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This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that
FDA website. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm. Accessed October 7, 2013. 23. Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA. 2011;305(22):2320-2326.ArticlePub...
5.Clinicaltrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02074839. Accessed September 1, 2023. 6.Pagliuca, S., Gurnari, C., & Visconte, V. (2021). Molecular Targeted Therapy in Myelodysplastic Syndromes: New Options for Tailored Treatments. Cancers, 13(4), 784. https://doi...
Design and implement a GCP-compliant safety system for clinical trials Early engagement with payers Learn more FDA interactions NDA/BLA planning Application and support for accelerated approval Pivotal study design and implementation Preparation of Module 3 (CMC) of the Common Technical Document (CTD) ...