Results 6 to 10 of 98

Clinical trials and Alien Tort Statute jurisdiction

USA - April 27 2010 Under what circumstances can a foreign plaintiff bring suit against U.S. companies for allegedly tortious actions that occurred abroad?

Philip Katz, Cate Stetson

FDA announces major proposed rule amending Hatch-Waxman regulations

USA - February 13 2015 On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed rule (80 FR 6802) to…

George A. O'Brien, David M. Fox, James R. Johnson, Philip Katz, Gary Veron

Federal Court Determines that Patient Has Liberty Interest in Receiving Investigational Drug

USA - May 24 2016 On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff's…

Lauren S. Colton

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

USA - January 19 2023 Study sponsors, investigators, study sites, CROs, and other clinical trial vendors should exercise renewed vigilance in light of FDA’s enhanced…

Heidi Gertner, Blake Wilson

Life sciences and health care horizons 2020

China, European Union, Japan, Mexico, United Kingdom, USA - February 19 2020 Japan is the world’s third largest Pharmaceutical market, and commentators Currently expect it to reach a value of US$105 Billion by 2021 (and US$109…

Alice Valder Curran, Virginia A. Gibson, Stephen Bennett, Melissa K. Bianchi, Hein van den Bos, Charles Brasted, Ina Brock, Celina Bujalska, Brooke Bumpers, Dr. Frederick Ch'en, Mike Druckman, William F. Ferreira, David M. Fox, Heidi Gertner, Dr. Rachel Gribben, Jennifer Agraz Henderson, David Horowitz, Imogen Ireland, Ronald L. Wisor, JR., Mitchell J. Lazris, Susan S. Lee, Agnieszka Majka, H. Todd Miller, Paul Otto, Dr. Marion Palmer, Kelliann H. Payne, Randy Prebula, Allison Pugsley, Ernesto Federico Algaba Reyes, Mikael Salmela, John Salmon, Dr. Jorg Schickert, Dr. Matthias Schweiger, Jodi Scott, John J. Smith, Joy Sturm, Jane Summerfield, Xin Tao, Cullen G. Taylor, Arne Thiermann, Salomé Cisnal De Ugarte, Anna Wiktorow, Marcy Wilder, Jessie Xie, Lu Zhou