Results 41 to 50 of about 1,710,685 (294)

An empirical analysis of overall survival in drug approvals by the US FDA (2006–2023)

Cancer Medicine
Background The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster ...
Josh Elbaz, Alyson Haslam, Vinay Prasad
doaj   +1 more source

REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY [PDF]

, 2016
Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature.
Darzi, A, Hughes-Hallett, A, Marcus, AP, Marcus, HJ, Nandi, D, Payne, CJ, Yang, GZ   +6 more
core   +2 more sources

Carcinomas and Carcinoid Tumors of the Lungs and Bronchi in Children and Adolescents: The EXPeRT Recommendations

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Primary lung carcinomas and bronchial carcinoid tumors (BC) are very rare malignancies in childhood. While typical BC and mucoepidermoid carcinomas are mostly low‐grade, localized tumors with a more favorable prognosis than in adults, necessitating avoidance of overtreatment, adenocarcinomas of the lung are often diagnosed at advanced disease ...
Michael Abele, Calogero Virgone, Michaela Kuhlen, Sabine Irtan, Yves Reguerre, Malgorzata Krawczyk, Ewa Bien, Tal Ben‐Ami, Maja Cesen, Ricardo Lopez‐Almaraz, Andrea Ferrari, Gianni Bisogno, Dominik T. Schneider, Abbas Agaimy, Constantin Lapa, Hubert Ducou le Pointe, Rainer Claus, Catherine Daniel, Ines B. Brecht, Daniel Orbach   +19 more
wiley   +1 more source

Results of the Childhood Cancer and Leukaemia Group's United Kingdom Relapsed Wilms Tumour Trial

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background The United Kingdom relapsed Wilms tumour (UKW‐R) trial aimed to improve the historically low survival rates after relapse of Wilms tumour (WT) through a prospective national risk‐stratified protocol. The trial also evaluated efficacy and toxicity of high‐dose melphalan.
Sucheta J. Vaidya, Veronica Moroz, Juliet Hale, Vesna Pavasovic, Rachel Hobson, Patricia Sartori, Daniel Saunders, Mark Powis, Gordan M. Vujanic, Stephen Baker, Kathy Pritchard‐Jones   +10 more
wiley   +1 more source

Delayed Access to Generic Medicine: A Comment on the Hatch-Waxman Act and the Approval Bottleneck [PDF]

, 2009
Prescription drug costs can be astronomical. The advent of generic drugs, which sell at substantially lower prices than their brand-name counterparts, can save consumers billions of dollars per year. The Hatch-Waxman Act, which governs the introduction
Patel, Ankur N.
core   +1 more source

European Standard Clinical Practice Guideline and EXPeRT Recommendations for the Diagnosis and Management of Gastroenteropancreatic Neuroendocrine Neoplasms in Children and Adolescents

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Pediatric gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs) are extremely rare and clinically heterogeneous. Management has largely been extrapolated from adult practice. This European Standard Clinical Practice Guideline (ESCP), developed by the EXPeRT network in collaboration with adult NEN experts, provides (adult) evidence ...
Michaela Kuhlen, Calogero Virgone, Antje Redlich, Michael Abele, Ricardo Lopez‐Almaraz, Tal Ben‐Ami, Ewa Bien, Gianni Bisogno, Maja Mazic Cesen, Andrea Ferrari, Malgorzata A. Krawczyk, Yves Reguerre, Dominik T. Schneider, Ines B. Brecht, Charlotte Rigaud, Bilgehan Yalcin, Rainer Claus, Christian Vokuhl, Constantin Lapa, Jörg Fuchs, Segolene Hescot, Thomas Walter, Julien Hadoux, Daniel Orbach   +23 more
wiley   +1 more source

Drug approval processes: A case study of rivaroxaban

Archives of Pharmacy Practice, 2013
Rivaroxaban, a Xa inhibitor, was recently approved (March 2013) in the setting of post-acute coronary syndromes (ACS) by the European Medicine Agency. This is in contrast to not being approved by the Food and Drug Agency in the United States for the same
Sally A Arif, Zainab Bilfaqi
doaj   +1 more source

Lack of Transparency in the Premarket Approval Process for Aquadvantage Salmon [PDF]

, 2013
After a lengthy premarket approval process, the Food and Drug Administration (FDA) has just deemed AquAdvantage Salmon, a fast-growing, genetically engineered salmon, safe for human consumption.
McEvilly, Michael P.
core   +1 more source

Impact of high-cost drugs for individual patient use [PDF]

, 2004
To document and describe the individual patient use (IPU) scheme at St Vincent's Hospital, Sydney in terms of submissions and approvals and assess the financial impact of the scheme on the hospital drug expenditure.
Brien, JE, Gallego, G, Melocco, T, Taylor, SJ   +3 more
core   +1 more source

Efficacy and Tolerability of Topotecan/Cyclophosphamide/Dinutuximab in Relapsed and Refractory High‐Risk Neuroblastoma: A Multi‐Institutional Retrospective Study

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Purpose Chemoimmunotherapy with irinotecan, temozolomide, and dinutuximab (I/T/DIN) has emerged as first‐line therapy for relapsed/refractory (r/r) high‐risk neuroblastoma (HRNB) in North America. Topotecan and cyclophosphamide (T/C) are often used in combination with dinutuximab in the setting of lack of response, progression, or incomplete ...
Benjamin J. Lerman, Madeleine King, Rajen Mody, Sara‐Jane Onyeama, Araz Marachelian, Thomas Cash, Sara M. Federico, Meaghan Granger, Ami V. Desai, Suzanne Shusterman, Jennifer H. Foster, Elizabeth Sokol, Chelsee Greer, Keri Streby, Holly J. Meany, Kieuhoa T. Vo, Margaret E. Macy, Rochelle Bagatell   +17 more
wiley   +1 more source