An open science pathway for drug marketing authorization-Registered drug approval. [PDF]
PLoS Medicine, 2021 Florian Naudet and co-authors propose a pathway involving registered criteria for evaluation and approval of new drugs.
Florian Naudet +4 more
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Orphan Drug Approval in Canada, 1999-2022: A Cross-sectional Study [PDF]
International Journal of Health Policy and ManagementThe number of drugs for orphan indications has been increasing significantly in Canada and the federal government recently announced an investment of $1.5 billion dollars over 3 years primarily directed at helping to fund the cost of these drugs.
Joel Lexchin
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Getting the Right Evidence After Drug Approval [PDF]
Frontiers in Pharmacology, 2020 To generate comparative evidence in a timely fashion for drugs without restricting or delaying access, value-based pricing and reimbursement could be conditioned on a prospective, post-approval evidence generation plan.
Rick A. Vreman +3 more
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Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States [PDF]
Clinical and Translational ScienceRegulatory guidance documents exist on surrogate endpoints in the United States. In Japan, there are no established rules or guidance regarding the use of surrogate endpoints, and various aspects remain unclear.
Yuko Yamamoto +3 more
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From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt [PDF]
PharmaceuticalsPharmacogenomics (PGx) is the hope for the full optimization of drug therapy while minimizing the accompanying adverse drug events that cost billions of dollars annually.
Fadya M. Elgarhy +7 more
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Disease modification in osteoarthritis; pathways to drug approval [PDF]
Osteoarthritis and Cartilage Open, 2020 Summary: Objective: To summarize proceedings of a workshop convened to discuss advances in disease modifying osteoarthritis (OA) drugs and regulatory challenges in bringing these drugs to market. Design: Summary of a one day workshop held in Washington,
Jeffrey N. Katz +7 more
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Drug approval prediction based on the discrepancy in gene perturbation effects between cells and humans [PDF]
EBioMedicine, 2023 Minhyuk Park, Donghyo Kim, Inhae Kim
exaly +2 more sources
Rheumatology and Therapy, 2023 Introduction This drug utilization study evaluated the impact of 2019 label changes on real-world febuxostat utilization among patients with gout. We describe the numbers and proportions of patients initiating febuxostat as new users (allopurinol-naïve ...
Alexandra Z. Sosinsky +4 more
doaj +1 more source
Review time of oncology drugs and its underlying factors: an exploration in China
Frontiers in Pharmacology, 2023 Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed.Methods: We ...
Xingyue Zhu, Bao Liu
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The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]
, 2018 Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D +6 more
core +2 more sources