| | Fundamentals of US Regulatory Affairs, 10th Edition by Various Contributors, Pamela Jones, Syed Rizwanuddin Ahmad, Cassie Alexander, Berry Berger, Mitchell Berger, Peggy Berry, Charles Breen, David Brindley, Elizabeth Campbell, Kell Canon, Carol Cooper, Pallavi Sharma Das, Sunny Kamlesh Dave, Seameen Dehdashti, Cindy Dibiasi, Jim Dibiasi, Joy Frestedt, Abhishek Gurnani, Robert Guzman, Michael Hinckle, Karen Jaffe, Jocelyn Jennings, Angela Johnnson, Kurt Karst, Allison Komiyama, Mona Koshkouei, Carrie Kuehn, Evangeline Loh, Demetra Macheras, Robert Martin, Nancy Mathewson, Kirsten Messmer, Bernard Naughton, Tina O'brien, Valerie Ramsey, Sarah Robinson, Joanne Rupprecht, Alexandra Beumer Sassi, Kathrin Scalper, Charity-Anne Schuller, Kandarp Shah, William Sietsema, Andrew Slade, James Smith, Edward Steele, Ashhish Talati, Nancy Teague, Snehal Trivedi, Gresham Weatherly, Martha Wells, Jennifer Wilhelm, Holly Winchell, Linda Yang Hardcover, Published 2017 by Regulatory Affairs Professional Society (Raps) ISBN-13: 978-0-9977697-7-7, ISBN: 0-9977697-7-7
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