U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant for Treatment-Resistant Depression
Katz, Eva G., McNulty, Pauline, Levitan, Bennett, Treichler, Patricia, Martynowicz, Jadwiga, Jamieson, Carol
Published in Therapeutic innovation & regulatory science (01.01.2022)
Published in Therapeutic innovation & regulatory science (01.01.2022)
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A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
Sforzini, Luca, Worrell, Courtney, Kose, Melisa, Anderson, Ian M., Aouizerate, Bruno, Arolt, Volker, Bauer, Michael, Baune, Bernhard T., Blier, Pierre, Cleare, Anthony J., Cowen, Philip J., Dinan, Timothy G., Fagiolini, Andrea, Ferrier, I. Nicol, Hegerl, Ulrich, Krystal, Andrew D., Leboyer, Marion, McAllister-Williams, R. Hamish, McIntyre, Roger S., Meyer-Lindenberg, Andreas, Miller, Andrew H., Nemeroff, Charles B., Normann, Claus, Nutt, David, Pallanti, Stefano, Pani, Luca, Penninx, Brenda W. J. H., Schatzberg, Alan F., Shelton, Richard C., Yatham, Lakshmi N., Young, Allan H., Zahn, Roland, Aislaitner, Georgios, Butlen-Ducuing, Florence, Fletcher, Christine, Haberkamp, Marion, Laughren, Thomas, Mäntylä, Fanni-Laura, Schruers, Koen, Thomson, Andrew, Arteaga-Henríquez, Gara, Benedetti, Francesco, Cash-Gibson, Lucinda, Chae, Woo Ri, De Smedt, Heidi, Gold, Stefan M., Hoogendijk, Witte J. G., Mondragón, Valeria Jordán, Maron, Eduard, Martynowicz, Jadwiga, Melloni, Elisa, Otte, Christian, Perez-Fuentes, Gabriela, Poletti, Sara, Schmidt, Mark E., van de Ketterij, Edwin, Woo, Katherine, Flossbach, Yanina, Ramos-Quiroga, J. Antoni, Savitz, Adam J., Pariante, Carmine M.
Published in Molecular psychiatry (01.03.2022)
Published in Molecular psychiatry (01.03.2022)
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