Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience

Autor: Laëtitia Belgodère, Joseph Emmerich, Nicolas Albin, Trystan Bacon, Pascale Daynes, Stéphane Vignot, Thierry Vial, Guillaume Renaud, Carole Le Saulnier, Corine Maillard-Couvreur, Mélanie Cachet, Marie-Laure Veyries, Rym Youdarene, Wahiba Oualikene-Gonin, Christelle Ratignier-Carbonneil, Patrick Maison

Publikováno v: Frontiers in Public Health, Vol 11 (2023)

Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including t

Externí odkaz: https://doaj.org/article/a9ff1c470a374598b3b60fd4f8e1cb47

Délais administratifs des RTU, effet sur l’accès à l’innovation dans le mélanome

Autor: Cécile Auger, Bernard Guillot, Adrien Monard, Nicolas Albin

Publikováno v: Bulletin du Cancer. 109:28-37

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::01c46543032d992df78a7e2cc5064250
https://doi.org/10.1016/j.bulcan.2021.11.007

Survival, cost and added therapeutic benefit of drugs granted early access through the French temporary authorization for use program in solid tumors from 2009 to 2019

Autor: Fiona Y.‐V. Pham, Emmanuelle Jacquet, Amina Taleb, Adrien Monard, Ghania Kerouani‐Lafaye, Florence Turcry, Liora Brunel, Françoise Grudé, Isabelle Yoldjian, Isabelle Sainte‐Marie, Lotfi Boudali, Jean‐Yves Blay, Nicolas Albin

Publikováno v: International journal of cancer. 151(8)

Decisions on market authorization (MA) and reimbursement have different durations across countries because of health technology assessment (HTA) procedures and negotiations between manufacturers and national authorities. To overcome this delay, Franc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f982c483de90a7b1832d0f5904b3bab8
https://pubmed.ncbi.nlm.nih.gov/35603979

[Administrative delays of temporary recommendation for use: Impact on access to innovation in melanoma]

Autor: Cécile, Auger, Bernard, Guillot, Adrien, Monard, Nicolas, Albin

Publikováno v: Bulletin du cancer. 109(1)

Melanoma has benefited in recent years from therapeutic innovations, which have improved overall survival of patients. France has developed a regulatory arsenal allowing faster access to innovative drugs before marketing authorization: temporary auth

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::ed4cb4746785afd1857de9574172d854
https://pubmed.ncbi.nlm.nih.gov/34972538

Early access to health products in France: Major advances of the French 'Conseil stratégique des industries de santé' (CSIS) to be implemented (modalities, regulations, funding)

Autor: Nicolas Albin, Frédéric Lavie, Lotfi Boudali, Céline Kauv, Natalie Hoog-Labouret, Anne-Céline Richard, Thibault de Chalus, Frédéric Chassagnol, Fabrice Meillier, Benjamin Mazaleyrat, Claire Le Jeunne, Olivier Blin, Adrien Monard, Brigitte Pouletty-Lefebvre, Mathilde Grande, Françoise Grudé, Estelle Fruchet, Jean-François Bergmann

Publikováno v: Thérapie
Thérapie, EDP Sciences-Depuis 2016, la revue Thérapie n’est plus publiée par EDP Sciences.> Therapies (Elsevier), 2019, 74 (1), pp.103-117. ⟨10.1016/j.therap.2018.12.002⟩

In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, art

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5ca63055a7973a0c336636e78a59d4c0
https://doi.org/10.1016/j.therap.2018.12.002