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1. Overview of the US Food and Drug Administration Regulatory Process

Author

Rebecca Robinson, Andrea Gray, Judith Arcidiacono, Laura Ricles, Carolyn Yong, Scott A. Brubaker, Lei Xu, Cynthia J. Chang, David S. Kaplan, Richard McFarland, and Anna Kwilas

Subjects
Food and drug administration, Process management, Process (engineering), Organizational structure, Product (category theory), Business, Regenerative medicine, health care economics and organizations
Abstract

This chapter provides a brief historical review of the US Food and Drug Administration (FDA) and its organizational structure and discusses the regulation of regenerative medicine products, possible regulatory pathways for combination products, and relevant jurisdictional issues. Sources of information concerning FDA regulatory policies important to regenerative medicine product developers are also discussed. Suggestions are provided regarding how to engage the FDA effectively during the development of a novel regenerative medicine product.

Published
2019

2. Contributors

Author

Rachit Agarwal, Jon D. Ahlstrom, Rafiq Ahmad, Emilio I. Alarcon, Alejandro J. Almarza, Graça Almeida-Porada, Manuel Almeida, Melissa Alvarado-Velez, James M. Anderson, Judith Arcidiacono, Anthony Atala, Stephen F. Badylak, Wayne Balkan, Brian G. Ballios, Pedro M. Baptista, M. Douglas Baumann, Supinder S. Bedi, Ravi V. Bellamkonda, Nicole M. Bergmann, Helen M. Blau, Joel D. Boerckel, Andres M. Bratt-Leal, James C. Brown, Scott Brubaker, Isabelle Brunette, Gisele A. Calderon, Arnold I. Caplan, David G. Castner, Cynthia Chang, Aditya Chawla, Xuguang Chen, Paul Cohen, Michael J. Cooke, Joshua S. Copus, Vitor M. Correlo, Charles S. Cox, Abritee Dahl, Richard M. Day, Paolo De Coppi, Mahesh C. Dodla, Jennifer H. Elisseeff, Juliet A. Emamaullee, Adam Esa, Yunlan Fang, Heather J. Faust, John P. Fisher, Matthew B. Fisher, Elvis L. Francois, Andrés J. García, Svetlana Gavrilov, Dan Gazit, Zulma Gazit, Christopher V. Gemmiti, Gregory J. Gillispie, Sarah E. Gilpin, W.T. Godbey, Andrea Gray, Ronald M. Green, May Griffith, Robert E. Guldberg, Qiongyu Guo, Geoffrey C. Gurtner, Michael C. Hacker, Issa A. Hanna, Joshua M. Hare, Konstantinos E. Hatzistergos, Ralf-Peter Herber, Jöns Hilborn, H. David Humes, Joshua G. Hunsberger, Kenjiro Iwasa, John D. Jackson, Margaret L. Jackson, Hae Lin Jang, John A. Jansen, Josephine Johnston, Carl Jorns, Huijun Kang, David L. Kaplan, David S. Kaplan, Adam J. Katz, Matthew W. Kelley, Kelsey Kennedy, Ali Khademhosseini, Gilson Khang, Jinho Kim, Rachel H. Klein, Irina Klimanskaya, Paul S. Knoepfler, In Kap Ko, Yash M. Kolambkar, Jan Krieghoff, Nathan W. Kucko, Manoj Kumar, Joanne Kurtzberg, Anna Kwilas, Donald W. Landry, Mark T. Langhans, Robert Lanza, Giacomo Lanzoni, Sang Jin Lee, Sander C.G. Leeuwenburgh, Kam W. Leong, Rui Liang, Volha Liaudanskaya, Hang Lin, Michael T. Longaker, Hermann P. Lorenz, Jeanne F. Loring, Shi-Jiang Lu, Alberto Lue, Peter X. Ma, Renata S. Magalhaes, Serena Mandla, Clement D. Marshall, Manuela Martins-Green, Devon E. Mason, Jonquil R. Mau, Richard McFarland, Melissa K. McHale, James C. Melville, Jason R. Meyers, Antonios G. Mikos, Jordan S. Miller, Paul A. Mittermiller, Hideki Miyachi, Shinka Miyamoto, Nelson Monteiro, Alessandra L. Moore, Sara Morini, Philipp T. Moser, Vivek J. Mukhatyar, Mark Murdock, Aaron Nagiel, Gail K. Naughton, Allison Nauta, Javier Navarro, Jared M. Newton, Aparna Nori, Teruo Okano, Joaquim M. Oliveira, Harald C. Ott, Jagannath Padmanabhan, Kristin M. Page, Anil Kumar Pallickaveedu Rajan Asari, Virginia E. Papaioannou, Jihoon Park, Samantha L. Payne, Gadi Pelled, Andrew Pepper, Elumalai Perumal, Melissa Petreaca, Christopher J. Pino, Alessandro Pirosa, Iris Pla-Palacín, Marta Pokrywczynska, Christopher D. Porada, Blaise D. Porter, Milica Radisic, Kunal J. Rambhia, F. Raquel Maia, Buddy D. Ratner, A.H. Reddi, Rui L. Reis, Laura Ricles, Camillo Ricordi, Muhammad Rizwan, Rebecca Robinson, Melanie Rodrigues, Benjamin B. Rothrauff, Hooman Sadri-Ardekani, Pilar Sainz-Arnal, Rangarajan Sambathkumar, Natalia Sánchez-Romero, Michelle Scarritt, Christopher M. Schneider, Steven D. Schwartz, Sarah Selem, Trinidad Serrano-Aulló, A.M. James Shapiro, Dmitriy Sheyn, Tatsuya Shimizu, Toshiharu Shinoka, Molly S. Shoichet, Toshihiro Shoji, Thomas Shupe, Andrew G. Sikora, Fiona Simpson, Aleksander Skardal, Daniel Skuk, Brandon T. Smith, Jihee Sohn, Shay Soker, Estela Solanas, Jeong Eun Song, Disha Sood, David L. Stocum, Stephen C. Strom, Jessica M. Sun, Hironobu Takahashi, Jacques P. Tremblay, Nirmalya Tripathy, John W. Tse, Rocky S. Tuan, Catherine M. Verfaillie, Gordana Vunjak-Novakovic, William R. Wagner, Yanling Wang, Emma Watson, Jennifer L. West, David F. Williams, James K. Williams, Mark E. Wong, Savio L-Y. Woo, Fiona M. Wood, Lei Xu, Doron C. Yakubovich, Yafeng Yang, Michael J. Yaszemski, Pamela C. Yelick, Evelyn K.F. Yim, Carolyn Yong, James J. Yoo, Simon Young, Nora Yucel, Rachel L. Zacharias, Yuanyuan Zhang, Ai Zhang, Jin Zhang, and Yang Zhu

Published
2018

3. Translation of Regenerative Medicine Products Into the Clinic in the United States

Author

Donald Fink, Michael Mendicino, Mohammad Heidaran, Lynne Boxer, Celia Witten, Charles N. Durfor, Brent McCright, John Hyde, Richard McFarland, Carmen Gacchina Johnson, Diana Yoon, Judith Arcidiacono, Lori Tull, Mark H. Lee, David S. Kaplan, Patrick Au, and Safa Karandish

Subjects
medicine.medical_specialty, Process (engineering), business.industry, Alternative medicine, Regenerative medicine, Product (business), Clinical trial, New product development, medicine, Relevance (law), Engineering ethics, Regulatory science, business, health care economics and organizations
Abstract

The field of regenerative medicine encompasses a breathtaking array of interdisciplinary scientific approaches with the promise of delivering future therapies to meet current unmet medical needs for patients. Increasingly more of these innovative products are being translated into human clinical trials in the United States, and general familiarity of the FDA is important to efficiently navigate the process. The basics of FDA history, organization, and processes are described herein for those new to clinical translation, with more detailed content added regarding approval pathways, regulations, guidances, and select special topics of relevance to regenerative medicine. In addition to the cumulative experience of previous products, the FDA regulatory approach to medical products evaluation includes an ongoing assessment of how the science of those products informs regulatory policy. FDA engages in ongoing dialogue with the scientific community and product sponsors to continue to develop science-based regulatory review policies that are robust and predictable in order to meet the needs of the challenging array of products that are on the horizon.

Published
2015

4. Contributors

Author

Mehran Abolbashari, Jaimo Ahn, Salem Akel, Julie G. Allickson, Graça Almeida-Porada, Judith Arcidiacono, Anthony Atala, Patrick Au, Danielle Aufiero, Pedro M. Baptista, Ronnda L. Bartel, Amelia Bartholomew, Elona Baum, Angie Botto-van Bemden, Khalil N. Bitar, Lynne Boxer, Matthew P. Brown, Heather L. Brown, Stephanie J. Bryant, Pedro P. Carvalho, Prafulla Chandra, John R. Chapman, Shreyasi Das, Daniel B. Deegan, Abritee Dhal, Albert D. Donnenberg, Matthew B. Durdy, Charles N. Durfor, Elazer R. Edelman, Donald Fink, Steven Fischkoff, Joyce L. Frey-Vasconcells, Tobias Führmann, Carmen Gacchina Johnson, Or Gadish, Sanjiv S. Gambhir, Adrian P. Gee, Manuela E. Gomes, Kurt D. Hankenson, Robert J. Hariri, Heather C. Hatcher, Mohammad Heidaran, Ralf Huss, John Hyde, Yoshito Ikada, Deepak Jain, Paul A. Jain, Jesse V. Jokerst, Philipp Jungebluth, Eve Kandyba, David S. Kaplan, Safa Karandish, F. Kurtis Kasper, Sneha S. Kelkar, Norma Kenyon, Krzysztof Kobielak, Jesse Kramer, Sang Jin Lee, Mark H. Lee, Yvonne Leung, Mei Ling Lim, Neil J. Littman, Paolo Macchiarini, Nafees N. Malik, Brenda K. Mann, Kacey G. Marra, Robert E. Marx, Lina Mastrangelo, Brent McCright, Richard McFarland, Michael Mendicino, Antonios G. Mikos, Nikolaos Mitrousis, Aaron M. Mohs, Thomas Moore, Emma C. Moran, Walter Niles, Guoguang Niu, Masashi Nomi, Tamara Nunez, Robert Perry, Robert P. Pfotenhauer, Christopher D. Porada, Kavitha Premenand, Glenn D. Prestwich, Shreya Raghavan, Mahendra Rao, Anthony Ratcliffe, Stephen Rego, Rui L. Reis, Ivan N. Rich, Márcia T. Rodrigues, J. Peter Rubin, Steven Sampson, Etai Sapoznik, John G. Sharp, Molly S. Shoichet, Daniel Skuk, Evan Y. Snyder, Shay Soker, Sita Somara, Tom Spencer, Suzanne Stewart, Premenand Sundivakkam, Erszebet Szilagyi, Alexander M. Tatara, Brian Tobe, Jacques P. Tremblay, Alan O. Trounson, Anup Tuladhar, Lori Tull, Jolene E. Valentin, Dipen Vyas, Zhan Wang, Alicia Winquist, Celia Witten, Mark E.K. Wong, James J. Yoo, Diana Yoon, Elie Zakhem, and Joao Paulo Zambon

Published
2015

5. List of Contributors

Author

Russell C. Addis, Piero Anversa, Judith Arcidiacono, Anthony Atala, Joyce Axelman, Ashok Batra, Helen M. Blau, Susan Bonner-Weir, Mairi Brittan, Hal E. Broxmeyer, Mara Cananzi, Constance Cepko, Tao Cheng, Susana M. Chuva de Sousa Lopes, Gregory O. Clark, Maegen Colehour, Paolo de Coppi, Giulio Cossu, George Q. Daley, Jiyoung M. Dang, Natalie Direkze, Yuval Dor, Gregory R. Dressler, Charles N. Durfor, Ewa C.S. Ellis, Martin Evans, Donna M. Fekete, Donald Fink, Elaine Fuchs, Margaret T. Fuller, Richard L. Gardner, Zulma Gazit, Dan Gazit, John D. Gearhart, Victor M. Goldberg, Rodolfo Gonzalez, Deborah Lavoie Grayeski, Ronald M. Green, Markus Grompe, Stephen L. Hilbert, Marko E. Horb, Jerry I. Huang, Jaimie Imitola, D. Leanne Jones, Jan Kajstura, David S. Kaplan, Pritinder Kaur, Kathleen C. Kent, Candace L. Kerr, Ali Khademhosseini, Nadav Kimelman, Irina Klimanskaya, Jennifer N. Kraszewski, Mark A. LaBarge, Robert Langer, Robert Lanza, Ellen Lazarus, Jean Pyo Lee, Mark H. Lee, Annarosa Leri, Shulamit Levenberg, S. Robert Levine, John W. Littlefield, Richard McFarland, Jill McMahon, Douglas A. Melton, Mary Tyler Moore, Franz-Josef Mueller, Christine L. Mummery, Bernardo Nadal-Ginard, Hitoshi Niwa, Keisuke Okita, Jitka Ourednik, Vaclav Ourednik, Kook I. Park, Ethan S. Patterson, Gadi Pelled, Christopher S. Potten, Sean Preston, Philip R. Roelandt, Valerie D. Roobrouck, Nadia Rosenthal, Janet Rossant, Maurilio Sampaolesi, Maria Paola Santini, David T. Scadden, Holger Schlüter, Gunter Schuch, Michael J. Shamblott, Dima Sheyn, Richard L. Sidman, Evan Y. Snyder, Shay Soker, Stephen C. Strom, Lorenz Studer, M. Azim Surani, Francesco Saverio Tedesco, Yang D. Teng, David Tosh, Alan Trounson, Tudorita Tumbar, Edward Upjohn, George Varigos, Catherine M. Verfaillie, Zhan Wang, Gordon C. Weir, Kevin J. Whittlesey, J. Koudy Williams, James W. Wilson, Celia Witten, Nicholas A. Wright, Shinya Yamanaka, and Jung U. Yoo

Published
2014

6. The Regulatory Process from Concept to Market

Author

Celia Witten, Donald Fink, Charles N. Durfor, Judith Arcidiacono, Alexander M. Bailey, Becky Robinson, Richard McFarland, Patricia Holobaugh, Rachael Anatol, Steve Winitsky, and Mark H. Lee

Subjects
Process (engineering), business.industry, Investigational New Drug Application, Pharmacology, Key issues, humanities, Food and drug administration, Product (business), Clinical research, Late phase, Clinical investigation, Medicine, Engineering ethics, business, health care economics and organizations
Abstract

The US Food and Drug Administration (FDA) is responsible for the regulatory oversight of a wide range of products, including cell-based products regulated by the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research. This chapter focuses on several key issues relevant to the development of cell-based products, including early and late phase considerations for chemistry, manufacturing, and controls; pharmacology/toxicology; and clinical testing. This chapter introduces the following topics: the regulatory process, sponsor meetings with OTAT, the requirements for submitting an investigational new drug application (IND), and FDA review of an original IND submission. Also discussed are combination products, tissue-engineered/regenerative medicine products, medical devices, special regulatory considerations such as clinical research involving children, responsibilities of sponsors and investigators, and the use of standards. Knowledge and consideration of the topics discussed in this chapter may aid in the development of cell-based product.

Published
2014

7. List of Contributors

Author

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, and Laurie Zoloth

Published
2014

8. Contributors

Author

Piero Anversa, Judith Arcidiacono, Anthony Atala, Yann Barrandon, Ashok Batra, Daniel Becker, Nicole M. Bergmann, Paolo Bianco, Helen M. Blau, Susan Bonner-Weir, Mairi Brittan, Hal E. Broxmeyer, Mara Cananzi, Arnold I. Caplan, Constance Cepko, Maegen Colehour, Giulio Cossu, George Q. Daley, Jiyoung M. Dang, Ayelet Dar, Brian R. Davis, Paolo de Coppi, Natalie Direkze, Juan Domínguez-Bendala, Yuval Dor, Gregory R. Dressler, Charles N. Durfor, Rita B. Effros, Ewa C.S. Ellis, Margaret A. Farley, Donna M. Fekete, Qiang Feng, Donald Fink, Elaine Fuchs, Dan Gazit, Zulma Gazit, Sharon Gerecht, Victor M. Goldberg, Rodolfo Gonzalez, François Gorostidi, Elizabeth Gould, Nicolas Grasset, Deborah Lavoie Grayeski, Ronald M. Green, Markus Grompe, Joshua M. Hare, Konstantinos E. Hatzistergos, Kevin E. Healy, Stephen L. Hilbert, Jerry I. Huang, James Huettner, Jaimie Imitola, Elizabeth F. Irwin, Joseph Itskovitz-Eldor, Josephine Johnston, Jan Kajstura, David S. Kaplan, Adam J. Katz, Pritinder Kaur, Erin A. Kimbrel, Nadav Kimelman, Chris Kintner, Naoko Koyano-Nakagawa, Tilo Kunath, Mark A. LaBarge, Robert Lanza, Stéphanie Lathion, Ellen Lazarus, Jean Pyo Lee, Mark H. Lee, Annarosa Leri, S. Robert Levine, Feng Li, Shi-Jiang Lu, John W. McDonald, Richard McFarland, Melissa K. McHale, Douglas A. Melton, Alexander F. Mericli, Christian Mirescu, Malcolm A.S. Moore, Mary Tyler Moore, Franz-Josef Mueller, Bernardo Nadal-Ginard, Jitka Ourednik, Vaclav Ourednik, Kook I. Park, Gadi Pelled, Antonello Pileggi, Jacob F. Pollock, Christopher S. Potten, Sean Preston, Nicole L. Prokopishyn, Camillo Ricordi, Pamela Gehron Robey, Ariane Rochat, Philip R. Roelandt, Valerie D. Roobrouck, Nadia Rosenthal, Janet Rossant, Maurilio Sampaolesi, Maria Paola Santini, David V. Schaffer, Holger Schlüter, Gunter Schuch, Sarah Selem, Dima Sheyn, Richard L. Sidman, Daniel Skuk, Evan Y. Snyder, Shay Soker, Stephen C. Strom, Lorenz Studer, Francesco Saverio Tedesco, Yang D. Teng, Jacques P. Tremblay, Tudorita Tumbar, Edward Upjohn, George Varigos, Catherine M. Verfaillie, Zhan Wang, Gordon C. Weir, Jennifer L. West, Kevin J. Whittlesey, J. Koudy Williams, J.W. Wilson, Celia Witten, Nicholas A. Wright, and Jung U. Yoo

Published
2013

9. Contributors

Author

Tamer Aboushwareb, Jon D. Ahlstrom, Alejandro J. Almarza, James M. Anderson, Judith Arcidiacono, Anthony Atala, Stephen F. Badylak, Jae Hyun Bae, Brian G. Ballios, Ashok Batra, M. Douglas Baumann, Ravi V. Bellamkonda, Nicole M. Bergmann, Mickie Bhatia, Martin A. Birchall, Helen M. Blau, Joel D. Boerckel, Ali H. Brivanlou, Mara Cananzi, Arnold I. Caplan, Joseph W. Carnwath, Grant A. Challen, George J. Christ, Hyun Jung Chung, Maegen Colehour, Michael J. Cooke, V.M. Correlo, Benjamin D. Cosgrove, Stefano Da Sacco, Jiyoung M. Dang, Richard M. Day, Paolo De Coppi, Roger E. De Filippo, Mahesh C. Dodla, Juan Domínguez-Bendala, Ryan P. Dorin, Charles N. Durfor, Rita B. Effros, Jennifer H. Elisseeff, Ewa C.S. Ellis, Juliet A. Emamaullee, Per Fagerholm, Qiang Feng, Donald Fink, Matthew B. Fisher, Andrés J. García, Svetlana Gavrilov, Dan Gazit, Zulma Gazit, Christopher V. Gemmiti, Charles A. Gersbach, Margaret A. Goodell, Deborah Lavoie Grayeski, Ronald M. Green, May Griffith, Robert E. Guldberg, Qiongyu Guo, M.C. Hacker, Joanne Hackett, Joshua M. Hare, Benjamin S. Harrison, Konstantinos E. Hatzistergos, Kevin E. Healy, Stephen L. Hilbert, Jiang Hu, Alexander Huber, H. David Humes, Elizabeth F. Irwin, Brett C. Isenberg, Takanori Iwata, Sam Janes, Lily Jeng, Junfeng Ji, Josephine Johnston, Kimberly A. Johnston, David L. Kaplan, David S. Kaplan, Sinan Karaoglu, Adam J. Katz, Jaehyun Kim, Erin A. Kimbrel, Nadav Kimelman, Jonathan A. Kluge, Chester J. Koh, Yash M. Kolambkar, Makoto Komura, Wilfried A. Kues, Francois Ng kee Kwong, Neil Lagali, Deepak A. Lamba, Donald W. Landry, Robert Lanza, Barrett Larson, Malcolm A. Latorre, Ellen Lazarus, Hyukjin Lee, Mark H. Lee, Sang Jin Lee, Gary G. Leisk, Feng Li, Rui Liang, Kuanyin K. Lin, Xiaohua Liu, Michael T. Longaker, H. Peter Lorenz, Shi-Jiang Lu, Andrea Lucas-Hahn, Peter X. Ma, Paolo Macchiarini, Masood A. Machingal, J.F. Mano, M. Martins-Green, Michael McCall, Richard McFarland, Melissa K. McHale, Alexander F. Mericli, A.G. Mikos, Vivek J. Mukhatyar, Allison Nauta, N.M. Neves, Heiner Niemann, Teruo Okano, Keisuke Okita, J.M. Oliveira, Virginia E. Papaioannou, Tae Gwan Park, Gadi Pelled, Laura Perin, M. Petreaca, Antonello Pileggi, Jacob F. Pollock, Blaise D. Porter, Milica Radisic, Nandini Rao, A.H. Reddi, Thomas A. Reh, R.L. Reis, Camillo Ricordi, Philip Roelandt, Caroline Beth Sangan, Justin M. Saul, David V. Schaffer, Gunter Schuch, Michael V. Sefton, Sarah Selem, A.M. James Shapiro, Heather Sheardown, Dima Sheyn, Molly S. Shoichet, Harvir Singh, Sirinrath Sirivisoot, Daniel Skuk, Shay Soker, Myron Spector, David L. Stocum, Stephen C. Strom, James A. Thomson, David Tosh, Robert T. Tranquillo, Jacques P. Tremblay, Catherine M. Verfaillie, Zhan Wang, Jennifer L. West, Kevin J. Whittlesey, Chrysanthi Williams, David F. Williams, J. Koudy Williams, Celia Witten, Savio L.-Y. Woo, Fiona Wood, Shinya Yamanaka, Masayuki Yamato, Saami K. Yazdani, James J. Yoo, Junying Yu, and Bonan Zhong

Published
2011

10. Overview of the FDA Regulatory Process

Author

David S. Kaplan, Donald Fink, Ashok Batra, Judith Arcidiacono, Richard McFarland, Celia Witten, Charles N. Durfor, Jiyoung M. Dang, Mark H. Lee, Maegen Colehour, Deborah Lavoie Grayeski, Stephen L. Hilbert, Kevin J. Whittlesey, and Ellen Lazarus

Subjects
Engineering, Sociology of scientific knowledge, Process (engineering), business.industry, Investigational New Drug, Guidance documents, Accounting, Guideline, Regenerative medicine, Public health service, Clinical research, Knowledge base, Code of Federal Regulations, Infectious disease (medical specialty), Cardiac valve, Medicine, Operations management, Regulatory science, Engineering ethics, Organizational structure, Business, Eligibility Determination, Enforcement
Abstract

Publisher Summary This chapter provides a brief historical review of the Food and Drug Administration (FDA) and its organizational structure and discusses topics pertaining to the regulation of regenerative medicine products including possible regulatory pathways for combination products and relevant jurisdictional issues. FDA regulations are contained in the Code of Federal Regulations (CFR). Regulations for drugs, biologics, devices, and tissues, along with related regulations, may be found in various parts of Title 21 of the CFR. Guidance documents are nonbinding publications that describe the FDA's interpretation of policy pertaining to a regulatory issue or set of issues related to the design, production, labeling, promotion, manufacturing, and testing of regulated products, the processing, content, and evaluation, or approval of submissions inspection, and enforcement policies. Guidance documents, which are developed in accordance with Good Guidance Practices found at 21 CFR §10.115, are intended to clarify the FDA's current thinking related to regulatory issues and procedures. The FDA has issued “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products to assist establishments making donor eligibility determinations with complying with the Donor Eligibility rule (21 CFR 1271 Subpart C).” This guidance also incorporates and finalizes the content of “Guidance for Industry, Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt–Jakob Disease (CJD) and Variant Creutzfeldt–Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The US Public Health Service (PHS) agencies including the FDA, National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Health Resources and Services Administration (HRSA) have worked together to address the risk of infectious disease transmission, publishing the “PHS Guideline on Infectious Disease Issues in Xenotransplantation.”

Published
2011

11. Overview of FDA Regulatory Process

Author

Donald Fink, Charles N. Durfor, Stephen L. Hilbert, David S. Kaplan, Deborah Lavoie, Ashok Batra, Celia Witten, Ellen Maher, and Richard McFarland

Subjects
Process management, Process (engineering), business.industry, Medicine, business
Published
2008

12. List of Contributors

Author

Jon D. Ahlstrom, Taby Ahsan, Julie Allickson, Alejandro J. Almarza, James M. Anderson, Peter Andrews, Hadi Aslan, Anthony Atala, Stephen F. Badylak, Ashok Batra, M. Douglas Baumann, Ravi V. Bellamkonda, Nicole M. Bergman, Z. Beyhan, Mickie Bhatia, Sangeeta N. Bhatia, Peter M. Black, Helen Blau, Scott D. Boden, Eric M. Brey, Ali H. Brivanlou, Chris R. Brown, Scott P. Bruder, S.M. Chambers, Christopher S. Chen, LiHow Chen, Mike Chen, Sulin Chen, N. Cheng, George J. Christ, Seyung Chung, J.B. Cibelli, Massimo Cimini, Paolo De Coppi, Mahesh C. Dodla, Juan Dominguez-Bendala, AM Doyle, Charles N. Durfor, Yann Echelard, Rita B. Effros, Jennifer Elisseeff, Ewa C.S. Ellis, Juliet A. Emamaullee, Carol A. Erickson, Roger De Filippo, Donald Fink, William H. Fissell, Gary E. Friedlaender, Mark E. Furth, Yossi Gafni, Keneth Gage, Andres Garcia, William Gavin, Daniel Gazit, Zulma Gazit, Christopher S. Gemmiti, Jörg C. Gerlach, Paul J. Gokhale, M.A. Goodell, May Griffith, Louis M. Guenin, Stefano Giuliani, Robert E. Guldberg, M.C. Hacker, Benjamin S. Harrison, Bernd Hartmann, Stephen H. Hilbert, Alexander Hillel, Jason Hipp, Col. J.B. Holcomb, Jeffrey O. Hollinger, Chantal E. Holy, Mariah Hout, Jiang Hu, George T.-J. Huang, Johnny Huard, Elliot E. Hui, H. David Humes, Marcos Intaglietta, Junfeng Ji, Yueha Jiang, Christa Johnen, Josephine Johnston, Akira Joraku, David L. Kaplan, David S. Kaplan, Gilson Khang, Rehan N. Khanzada, Soon Hee Kim, Moon Suk Kim, Nadav Kimelman, Irina Klimanskaya, Jonathan A. Kluge, Yash Kolambkar, Chester J. Koh, Makoto Komura, Douglas Kondziolka, Deniz Konya, Wilfried A. Kues, Francois Ng kee Kwong, Deepak Lamba, Hai Bang Lee, Hyukjin Lee, Gary G. Leisk, Kam W. Leong, Ariel J. Levine, Ren Ke Li, Wan-Ju Li, Grace J. Lim, Yan Lin, William J. Lindblad, Wendy F. Liu, Xiaohua Liu, Andrea Lucas-Hahn, Aernout Luttun, Samuel Lynch, Peter X. Ma, Ellen Maher, Manuela Martins-Green, Randall E. McClelland, Richard McFarland, Larry V. McIntire, Harry Meade, David L. Melican, A.G. Mikos, Fernando Ulloa Montoya, Robert M. Nerem, Heiner Niemann, Aparna Nori, Patrea L. Pabst, Kook In Park, Tae Gwan Park, David P. Patterson, Karen Pauwelyn, Gadi Pelled, Laura Perin, M. Petreaca, Antonello Pileggi, Jason H. Pomerantz, Blaise Porter, Milica Radisic, Buddy D. Ratner, A. Hari Reddi, Thomas A. Reh, Lola M. Reid, Camillo Ricordi, Jeff Ross, Alan J. Russell, Filipe N.C. Santos, John P. Schmitz, Gunter Schuch, Sargis Sedrakyan, Michael V. Sefton, Marta Serafini, Paulesh Shah, A.M. James Shapiro, Heather Sheardown, Molly S. Shoichet, M. Minhaj Siddiqui, Richard L. Sidman, Ronald Silverman, Daniel Skuk, Evan Snyder, Shay Soker, Myron Spector, David L. Stocum, Stephen C. Strom, Doris A. Taylor, Yang D. Teng, James Thomson, Robert T. Tranquillo, Jacques P. Tremblay, Amy Tsai, Rocky S. Tuan, Ross S. Tubo, Mark Van Dyke, Deborah Vavoie, Catherine Verfaillie, F. Jerry Volenec, Sara Wargo, Joseph W. Warnwath, Lawrence Wechsler, Shen Wei, Richard D. Weisel, Jennifer L. West, Chrysanthi Williams, J. Koudy Williams, Celia Witten, Steven E. Wolf, Savio L.-Y. Woo, Jordan H. Wosnick, Christine Wrenzycki, Munira Xaymardan, Hsin-Lei Yao, Saami K. Yazdani, Pamela C. Yelick, James J. Yoo, Junying Yu, Katrin Zeilinger, Lepeng Zeng, Andrey G. Zenovich, Bonan Zhong, Carol A. Ziomek, and Laurie Zoloth

Published
2008

Catalog

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