Results 51 to 60 of about 5,545,002 (288)

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

Pragmatic clinical trials in the context of regulation of medicines

Upsala Journal of Medical Sciences, 2019
The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data.
Rolf Gedeborg, Charles Cline, Björn Zethelius, Tomas Salmonson   +3 more
doaj   +1 more source

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

Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety [PDF]

, 2015
Abiraterone acetate (AA) is a potent, selective androge (CYP17) biosynthesis inhibitor, which showed to improve overall survival (HR = 0.646) in mCRPC patients progressing after docetaxel.
A., Giuli, A., Pellegrino, D., Santini, E. M., Ruggeri, E., Cortesi, F., Angelini, F., Longo, F., Primi, I., Sperduti, M. A., Fabbri, M. G., Chilelli, M. L., Mancini, Marchetti, Paolo, Milano, Annalisa, R., Ratta, S., Quadrini, T., Gamucci   +16 more
core   +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  

Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis Under the Sherman Act and the Noerr-Pennington Doctrine [PDF]

, 2017
The Hatch-Waxman Act of 1984 regulates approval by the Food and Drug Administration (“FDA”) of generic counterparts to patented drugs. In a series of recent cases, large pharmaceutical companies have been accused of exploiting Hatch-Waxman in violation ...
Resek, John F., Ph.D.
core   +2 more sources

Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016

JAMA Network Open, 2020
Key Points Question What are the available data on cancer treatment outcomes for new cancer therapies approved by the US Food and Drug Administration?
Aviv Ladanie, A. Schmitt, B. Speich, F. Naudet, A. Agarwal, Tiago V. Pereira, F. Sclafani, A. Herbrand, M. Briel, J. Martín-Liberal, Thomas Schmid, Hannah Ewald, J. Ioannidis, H. Bucher, B. Kasenda, L. Hemkens   +15 more
semanticscholar   +1 more source

Ethical Issues in the Drug Approval Process [PDF]

, 2013
The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for ...
McInnis, Meghan
core   +1 more source

Antibody-drug conjugates in cancer therapy: current advances and prospects for breakthroughs

Frontiers in Cell and Developmental Biology
Antibody-drug conjugates (ADCs), often referred to as “intelligent biological missiles,” have garnered significant attention in the rapidly evolving landscape of cancer therapy. ADCs represent a sophisticated approach by integrating monoclonal antibodies
Dan Wu, Dan Wu, Dan Wu, Kaixuan Yang, Kaixuan Yang, Runjia He, Rutie Yin, Rutie Yin, Lin Shui, Lin Shui   +9 more
doaj   +1 more source

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

JAMA Network Open, 2020
Key Points Question Have the number and characteristics of pivotal efficacy trials supporting US Food and Drug Administration approval of new drugs and biologics changed during the past 3 decades?
A. Zhang, Jeremy Puthumana, Nicholas Downing, N. Shah, H. Krumholz, J. Ross   +5 more
semanticscholar   +1 more source