United States Food and Drug Administration Regulation of Gene and Cell Therapies

Autor: Zenobia Taraporewala, Steve Winitsky, Judith Arcidiacono, Alexander M. Bailey, Kimberly A Benton

Publikováno v: Advances in Experimental Medicine and Biology ISBN: 9783319186177

The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::6c952ee564cc2c0f3d549bb33d0ca2c5
https://doi.org/10.1007/978-3-319-18618-4_1

List of Contributors

Autor: Robby D. Bowles, Anthony J. (Tony) Smith, Jon D. Ahlstrom, Julie Albon, Peter G. Alexander, Richard A. Altschuler, Pedro Alvarez, A. Amendola, Rachael Anatol, Nasim Annabi, Piero Anversa, Judith Arcidiacono, Anthony Atala, Kyriacos A. Athanasiou, François A. Auger, Debra T. Auguste, Hani A. Awad, Stephen F. Badylak, Alexander M. Bailey, Michael P. Barry, Daniel Becker, Visar Belegu, Jonathan Bernhard, Timothy Bertram, Valérie Besnard, Z.F. Bhat, Hina Bhat, Sangeeta N. Bhatia, Sarindr Bhumiratana, Paolo Bianco, Catherine Clare Blackburn, Thomas Bollenbach, Lawrence A. Bonassar, Mike Boulton, Amy D. Bradshaw, Christopher K. Breuer, Luke Brewster, Eric M. Brey, Mairi Brittan, Bryan N. Brown, T. Brown, J.A. Buckwalter, Deborah Buffington, Karen J.L. Burg, Timothy C. Burg, Stéphane Chabaud, Thomas Ming Swi Chang, Yunchao Chang, Robert G. Chapman, Fa-Ming Chen, Una Chen, Elisa Cimetta, Richard A.F. Clark, Karen L. Clark, Muriel A. Cleary, Réjean Cloutier, Clark K. Colton, George Cotsarelis, Ronald G. Crystal, Gislin Dagnelie, Lino da Silva Ferreira, Jeffrey M. Davidson, Thomas F. Deuel, Natalie Direkze, Gregory R. Dressler, Charles N. Durfor, Craig L. Duvall, George Eng, George Engelmayr, Thomas Eschenhagen, Mark Eu-Kien Wong, Vincent Falanga, Katie Faria, Denise L. Faustman, Dario O. Fauza, Qiang Feng, Lino Ferreira, Donald W. Fink, William Fissell, Lisa E. Freed, Mark E. Furth, Denise Gay, Sharon Gerecht-Nir, Lucie Germain, Charles A. Gersbach, Francine Goulet, Ritu Goyal, Maria B. Grant, Howard P. Greisler, Farshid Guilak, Brendan A.C. Harley, David A. Hart, Abdelkrim Hmadcha, Steve J. Hodges, Heidi R. Hofer, Jeffrey O. Hollinger, Patricia Holobaugh, Jeffrey A. Hubbell, H. David Humes, Donald E. Ingber, Beau Inskeep, Xingyu Jiang, Jan Kajstura, Ravi S. Kane, Jeffrey M. Karp, F. Kurtis Kasper, Ali Khademhosseini, Sven Kili, Erin A. Kimbrel, Irina Klimanskaya, Joachim Kohn, Shaun M. Kunisaki, Themis R. Kyriakides, Eric Lagasse, Jean Lamontagne, Robert Langer, Robert Lanza, Shimon Lecht, Benjamin W. Lee, Chang H. Lee, Mark H. Lee, Peter I. Lelkes, Annarosa Leri, David W. Levine, Feng Li, Michael T. Longaker, Javier López, Shi-Jiang Lu, Ying Luo, Ben D. MacArthur, Nancy Ruth Manley, Rohan Manohar, Jonathan Mansbridge, Athanasios Mantalaris, Jeremy J. Mao, J.L. Marsh, David C. Martin, J.A. Martin, M. Martins-Green, Koichi Masuda, Mark W. Maxfield, Kathryn L. McCabe, John W. McDonald, Richard McFarland, Antonios G. Mikos, José del R. Millán, Josef M. Miller, Shari Mills, Kristen L. Moffat, Mark J. Mondrinos, Daniel T. Montoro, Malcolm A.S. Moore, Rebekah A. Neal, Robert M. Nerem, Shengyong Ng, Craig Scott Nowell, Haruko Obokata, Bjorn Reino Olsen, Richard O.C. Oreffo, Regis J. O’Keefe, Kathy O’Neill, Ophir Ortiz, Carolyn K. Pan, Vikas Pathak, M. Petreaca, Daniela Pezzolla, Maksim V. Plikus, Julia M. Polak, Mark Post, Sean Preston, Aleš Prokop, Milica Radisic, Egon Ranghini, Yehoash Raphael, A.H. Reddi, Herrmann Reichenspurner, Ellen Richie, Pamela Gehron Robey, Becky Robinson, Anabel Rojas, Shuvo Roy, Alan J. Russell, Rajiv Saigal, W. Mark Saltzman, Ali Samadikuchaksaraei, Athanassios Sambanis, Jochen Schacht, Stacey C. Schutte, Lyndsey Schutte, Steven D. Schwartz, Robert E. Schwartz, Lori A. Setton, Su-Hua Sha, Jing Shan, Paul T. Sharpe, Songtao Shi, Arun R. Shrivats, Franck Simon, Dario Sirabella, J.M.W. Slack, Bernat Soria, Patrick Spicer, Kelly R. Stevens, Frank E. Stockdale, H. Christiaan Stronks, Lorenz Studer, Shuichi Takayama, James A. Thomson, Jordan E. Trachtenberg, Elsa Treffeisen, Rocky S. Tuan, Charles A. Vacanti, Joseph P. Vacanti, Cor van der Weele, Matthew Vincent, Gordana Vunjak-Novakovic, Lars U. Wahlberg, Derrick C. Wan, Anne Wang, Angela J. Westover, George M. Whitesides, Jeffrey A. Whitsett, Steve Winitsky, Celia Witten, Stefan Worgall, Nicholas A. Wright, Ioannis V. Yannas, Simon Young, Junying Yu, Zheng Zhang, Wenfu Zheng, Wolfram Hubertus Zimmermann, Laurie Zoloth

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::99ac7a7769e003732d58cbb379370d26
https://doi.org/10.1016/b978-0-12-398358-9.04001-5