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.
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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.
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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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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
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Predictors of orphan drug approval [PDF]
Orphanet Journal of Rare Diseases, 2010 Results More orphan drugs were developed in the US during the first ten years of the US Orphan Drug Act (1983-1992, N=73) and during the first ten years of the EU Regulation on Orphan Medicinal products (2000-2009, N=112) than in the EU (2000-2009, N=59). Orphan drug approval was strongly associated with previous experiences of the sponsor in obtaining
Heemstra Harald
doaj +3 more sources
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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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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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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Clinical and Translational Science, 2021 The current success rate of a drug candidate, from the beginning of the clinical trial to receiving marketing approval, is about 10%–20%, and it has not changed during the past few decades. Therefore, pharmaceutical companies are under pressure to select
Shingo Yamaguchi +2 more
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