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Results for 'Expanded access'

Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
OVN Avatar Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years

Innovation, Expanded access, Early drug access, Cancer, FDA, EMA

Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA). France has implemented the ATU (Temporary Authorization for Use) program to facil…

Apr 7th • 12 mins read

Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption
OVN Avatar John Hair, Thomas Maryon, and Cristian Lieneck
Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption

oncology, cancer, biosimilar, barriers, access, obstacles

Biosimilars are biologic medical products that are almost identical to original biologics but are produced by different companies. They are safe, effective, and can reduce costs for insurers and patients. Despite the benefits, barriers exist for oncologists and cancer centers in prescribing biosi…

Oct 27th • 30 mins read

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