Fundamentals of US Regulatory Affairs by James Smith, Martha Wells, Sarah Robinson, Robert Martin, Carol Cooper, Cassie Alexander, Joanne Rupprecht, Jocelyn Jennings, Seameen Dehdashti, Karen Jaffe, Evangeline Loh, Demetra Macheras, Nancy Mathewson, Kandarp Shah, Nancy Teague, Gresham Weatherly, Syed Rizwanuddin Ahmad, Berry Berger, Mitchell Berger, Peggy Berry, Charles Breen, David Brindley, Fernando Henrique X. de Brito, Elizabeth Campbell, Kell Canon, Pallavi Sharma Das, Sunny Kamlesh Dave, Cindy DiBiasi, Jim DiBiasi, Joy Frestedt, Abhishek Gurnani, Robert Guzman, Michael Hinckle, Angela Johnnson, Kurt Karst, Allison Komiyama, Mona Koshkouei, Carrie Kuehn, Kirsten Messmer, Bernard Naughton, Tina O'Brien, Valerie Ramsey, Alexandra Beumer Sassi, Kathrin Scalper, Charity-Anne Schuller, William Sietsema, Andrew Slade, Edward Steele, Ashhish Talati, Snehal Trivedi, Jennifer Wilhelm, Holly Winchell, Linda Yang