Results 41 to 50 of about 4,469 (118)

A Comprehensive Overview of US-FDA-Approved Anticancer Drugs and Biologics in 2023: An Observational Study

Journal of Pharmacy and Bioallied Sciences
Background: The United States Food and Drug Administration (US FDA) is responsible for ensuring public health by conducting a comprehensive assessment and approval of pharmaceuticals, medical devices, and food products.
Ajay Kumar Shukla, Saurav Misra
doaj   +1 more source

Current status of radiation countermeasures for acute radiation syndrome under advanced development

Journal of Radiation and Cancer Research, 2018
The availability of safe and effective radiation countermeasures for the military and civilian population represents a significant unmet medical need. To expedite the development of countermeasures for life-threating situations, the United States Food ...
Vijay K Singh, Oluseyi O Fatanmi, Paola T Santiago, Madison Simas, Briana K Hanlon, Melissa Garcia, Stephen Y Wise   +6 more
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FDA and Its Role in Drug Development

Journal of the Advanced Practitioner in Oncology, 2021
JADPRO Live 2020 was honored to have Dr. Richard Pazdur, the Director of the Oncology Center of Excellence at the FDA, discuss recent changes to oncology drug development and the approval process, the roles of the advanced practitioner in the execution of clinical trials, and changes that have taken place as a result of the COVID-19 pandemic.
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Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation

BMC Cancer, 2019
Background The low data publication rate for Food and Drug Administration (FDA)-approved drugs, and discrepancies between FDA-submitted versus published data, remain a concern. We investigated the publication statuses of sponsor-submitted clinical trials
Kenji Omae, Yuki Kataoka, Yasushi Tsujimoto, Yusuke Tsutsumi, Yosuke Yamamoto, Shunichi Fukuhara, Toshi A. Furukawa   +6 more
doaj   +1 more source

New Oncologic Drugs from 2008 to 2023—Differences in Approval and Access between the United States, Europe and Brazil

Current Oncology
Introduction: Advancements in oncology have revolutionized cancer treatment, with new drugs being approved at different rates worldwide. Our objective was to evaluate the approval of new oncological drugs for solid tumors by the Food and Drug ...
Rafael Balsini Barreto, Andressa Moretti Izidoro, Mario Henrique Furlanetto Miranda   +2 more
doaj   +1 more source

Expanding regulatory science: Regulatory complementarity and reliance

Clinical and Translational Science
Drug regulatory institutions, infrastructures, and systems are becoming increasingly interconnected across national boundaries and increasingly global in outlook. This process is reflected in the broadening and deepening application of the principles and
Jackson K. Mukonzo, Helen Byomire Ndagije, George Tsey Sabblah, Wangui Mathenge, David A. Price, Thaddeus H. Grasela   +5 more
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Publication of clinical trials supporting successful new drug applications: a literature analysis.

PLoS Medicine, 2008
BackgroundThe United States (US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submitted clinical trials. The publication status of these trials in the medical literature and factors associated with publication have not been ...
Kirby Lee, Peter Bacchetti, Ida Sim
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Bridging the new drug access gap between China and the United States and its related policies

Frontiers in Pharmacology
Introduction: The access gap for novel pharmaceuticals between China and the developed countries is a major public health issue in China. It is crucial to understand the determinants of this gap to ensure timely access to new drugs and enhance patient ...
Xingyue Zhu, Yang Chen
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ADME Gene-Related Pharmacogenomic Labeling of FDA-Approved Drugs: Comparison with Clinical Pharmacogenetics Implementation Consortium (CPIC) Evidence Levels

Medicines
Pharmacogenomics (PGx) can facilitate the transition to patient-specific drug regimens and thus improve their efficacy and reduce toxicity. The aim of this study was to evaluate the overlap of PGx classification for drug absorption, distribution ...
Subrata Deb, Robert Hopefl, Anthony Allen Reeves, Dena Cvetkovic   +3 more
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Tertiary Patents on Drugs Approved by the FDA

JAMA Health Forum
Importance Manufacturers of drug-device combinations, such as inhalers and injectable medications, often obtain patents not just on the active pharmaceutical ingredients of these products (primary patents) but also on other features, such as their formulations and methods of use (secondary patents) and delivery ...
Teng, Theodore W., Tu, S. Sean, Mooney, Helen, Bendicksen, Liam, Gabriele, Sarah M. E., Wouters, Olivier J., Feldman, William B.   +6 more
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