Results 41 to 50 of about 4,498,317 (372)

Ten‐Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs

Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease, 2020
Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals.
M. Khan, Izza Shahid, T. Siddiqi, Safi U. Khan, Haider J. Warraich, S. Greene, J. Butler, E. Michos   +7 more
semanticscholar   +1 more source

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

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   +1 more source

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

Revista Panamericana de Salud Pública, 2021
Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are ...
Carlos E. Durán, Martín Cañás, Martín A. Urtasun, Monique Elseviers, Tatiana Andia, Robert Vander Stichele, Thierry Christiaens   +6 more
doaj   +1 more source

The challenges of access to innovative medicines with limited evidence in the European Union

Frontiers in Pharmacology, 2023
The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases.
Antonio Vallano, Antonio Vallano, Antonio Vallano, Caridad Pontes, Caridad Pontes, Caridad Pontes, Antònia Agustí, Antònia Agustí   +7 more
doaj   +1 more source

DCcov: Repositioning of Drugs and Drug Combinations for SARS-CoV-2 Infected Lung through Constraint-Based Modelling [PDF]

, 2021
The 2019 coronavirus disease (COVID-19) became a worldwide pandemic with currently no effective antiviral drug except treatments for symptomatic therapy. Flux balance analysis is an efficient method to analyze metabolic networks. It allows optimizing for a metabolic function and thus e.g., predicting the growth rate of a specific cell or the production
arxiv   +1 more source

The use of mechanistic evidence in drug approval

Journal of Evaluation In Clinical Practice, 2018
The role of mechanistic evidence tends to be under‐appreciated in current evidence‐based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme
J. Aronson, A. La Caze, Michael P Kelly, Veli-Pekka Parkkinen, Jon Williamson   +4 more
semanticscholar   +1 more source

NeuroCADR: Drug Repurposing to Reveal Novel Anti-Epileptic Drug Candidates Through an Integrated Computational Approach [PDF]

arXiv, 2023
Drug repurposing is an emerging approach for drug discovery involving the reassignment of existing drugs for novel purposes. An alternative to the traditional de novo process of drug development, repurposed drugs are faster, cheaper, and less failure prone than drugs developed from traditional methods.
arxiv  

A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers

Clinical pharmacology and therapy, 2018
Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true for drugs used to treat minor cancers remains unknown.
Kenji Yamashita, M. Kaneko, M. Narukawa
semanticscholar   +1 more source

The Impasse on Overall Survival in Oncology Reimbursement Decision-Making: How Can We Resolve This?

Cancer Management and Research, 2021
Michael Patrick Lux, 1 Oriana Ciani, 2 William CN Dunlop, 3 Andrea Ferris, 4 Michael Friedlander 5 1Department of Gynecology and Obstetrics, Frauenklinik St. Louise Paderborn, St. Josefs-Krankenhaus Salzkotten, Frauen- und Kinderklinik St.
Lux MP, Ciani O, Dunlop WCN, Ferris A, Friedlander M   +4 more
doaj  

Aducanumab for Alzheimer’s disease: the never‐ending story that nurses should know [PDF]

, 2021
In October 2019, the American pharmaceutical company Biogen stated intention to apply to the US Food and Drug Administration (FDA) for the candidate drug aducanumab to be licenced as a therapeutic agent for the treatment of Alzheimer's disease (AD).
Bressington, D., Bressington, D., Petch, J., Petch, J.   +3 more
core   +2 more sources