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 +7 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
doaj +3 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
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
doaj +2 more sources
Drugs, Devices, and the FDA: Part 1 [PDF]
JACC: Basic to Translational Science, 2016 Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world.
Gail A. Van Norman, MD
doaj +3 more sources
Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post‐approval in Japan [PDF]
Pharmacology Research & Perspectives, 2023 Recently, post‐marketing safety measures have been considered critical in Japan due to the globalization of drug development and the introduction of new drug approval systems.
Rieko Saito, Seiko Miyazaki
doaj +2 more sources
Adapting drug approval pathways for bacteriophage-based therapeutics [PDF]
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
doaj +2 more sources
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 +2 more sources
ChemAP: predicting drug approval with chemical structures before clinical trial phase by leveraging multi-modal embedding space and knowledge distillation [PDF]
Scientific ReportsRecent studies showed that the likelihood of drug approval can be predicted with clinical data and structure information of drug using computational approaches. Predicting the likelihood of drug approval can be innovative and of high impact.
Changyun Cho +4 more
doaj +2 more sources
A new approach to psychiatric drug approval in Europe. [PDF]
PLoS Medicine, 2013 Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value ...
Corrado Barbui, Irene Bighelli
doaj +2 more sources