A decade of FDA-approved drugs (2010–2019): trends and future directions
A total of 378 novel drugs and 27 biosimilars approved by the US Food and Drug
Administration (FDA) between 2010 and 2019 were evaluated according to approval …
Administration (FDA) between 2010 and 2019 were evaluated according to approval …
Brief overview of approaches and challenges in new antibiotic development: a focus on drug repurposing
Drug repurposing, or identifying new uses for existing drugs, has emerged as an alternative
to traditional drug discovery processes involving de novo synthesis. Drugs that are currently …
to traditional drug discovery processes involving de novo synthesis. Drugs that are currently …
FDA approval and regulation of pharmaceuticals, 1983-2018
Importance US law requires testing of new drugs before approval to ensure that they provide
a well-defined benefit that is commensurate with their risks. A major challenge for the US …
a well-defined benefit that is commensurate with their risks. A major challenge for the US …
Failure of investigational drugs in late-stage clinical development and publication of trial results
TJ Hwang, D Carpenter, JC Lauffenburger… - JAMA internal …, 2016 - jamanetwork.com
Importance Many investigational drugs fail in late-stage clinical development. A better
understanding of why investigational drugs fail can inform clinical practice, regulatory …
understanding of why investigational drugs fail can inform clinical practice, regulatory …
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
Objective To characterize the therapeutic value of new drugs approved by the US Food and
Drug Administration (FDA) and European Medicines Agency (EMA) and the association …
Drug Administration (FDA) and European Medicines Agency (EMA) and the association …
Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration
Importance Drugs treating serious or life-threatening conditions can receive US Food and
Drug Administration (FDA) accelerated approval based on showing an effect in surrogate …
Drug Administration (FDA) accelerated approval based on showing an effect in surrogate …
New drugs: where did we go wrong and what can we do better?
B Wieseler, N McGauran, T Kaiser - Bmj, 2019 - bmj.com
New drugs: where did we go wrong and what can we do better? Page 1 New drugs: where did
we go wrong and what can we do better? More than half of new drugs entering the German …
we go wrong and what can we do better? More than half of new drugs entering the German …
Cancer therapy approval timings, review speed, and publication of pivotal registration trials in the US and Europe, 2010-2019
Importance Ensuring patients have access to safe and efficacious medicines in a timely
manner is an essential goal for regulatory agencies, one which has particular importance in …
manner is an essential goal for regulatory agencies, one which has particular importance in …
Identifying mutations in epilepsy genes: impact on treatment selection
P Perucca, E Perucca - Epilepsy research, 2019 - Elsevier
The last decade saw impressive advances not only in the discovery of gene mutations
causing epilepsy, but also in unraveling the molecular mechanisms underlying the clinical …
causing epilepsy, but also in unraveling the molecular mechanisms underlying the clinical …
[HTML][HTML] Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000–2015
A Vivot, J Jacot, JD Zeitoun, P Ravaud, P Crequit… - Annals of …, 2017 - Elsevier
Background Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical
benefit of new drugs for treating advanced solid tumors at the time of their approval by the …
benefit of new drugs for treating advanced solid tumors at the time of their approval by the …