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
doaj +3 more sources
From Concept to Regulatory Drug Approval: Lessons for Theranostics. [PDF]
J Nucl Med, 2022 Radiopharmaceutical therapy is an emerging treatment modality that has demonstrated increasing importance as a significant component in the treatment of cancer.
Perera M, Morris MJ.
europepmc +2 more sources
FDA Drug Approval and the Ethics of Desperation. [PDF]
JAMA Intern Med, 2021 In justifying the accelerated approval of aducanumab (Aduhelm; Biogen), US Food and Drug Administration (FDA) officials emphasized that many patients with Alzheimer disease and their families “made it clear that they are willing to accept the trade-off ...
Largent EA, Peterson A, Lynch HF.
europepmc +2 more sources
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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Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness. [PDF]
Front Med (Lausanne), 2021 International drug regulators use conditional drug approval mechanisms to facilitate faster patient access to drugs based on a lower evidentiary standard typically required of drug approvals. Faster and earlier access is justified by limiting eligibility
McPhail M, Weiss E, Bubela T.
europepmc +2 more sources
Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis. [PDF]
Clin Pharmacol Ther, 2021 The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first‐in‐world approvals and clarify the current ...
Tanaka M +10 more
europepmc +2 more sources
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
doaj +2 more sources
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
doaj +2 more sources
Are drug targets with genetic support twice as likely to be approved? Revised estimates of the impact of genetic support for drug mechanisms on the probability of drug approval. [PDF]
PLoS Genet, 2019 Despite strong vetting for disease activity, only 10% of candidate new molecular entities in early stage clinical trials are eventually approved. Analyzing historical pipeline data, Nelson et al. 2015 (Nat.
King EA, Davis JW, Degner JF.
europepmc +2 more sources
Adapting drug approval pathways for bacteriophage-based therapeutics
Frontiers in Microbiology, 2016 The global rise of multi-drug resistant bacteria has resulted in the notion that an antibiotic apocalypse is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long
Callum Cooper +3 more
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