Jennifer Agraz Henderson

Hogan Lovells

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COVID-19’s impact on clinical trials prompts FDA to issue guidance to assist with study conduct

USA - March 19 2020 On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19…

Robert Church, William F. Ferreira, Heidi Gertner, Randy Prebula, Blake E. Wilson, Justin Yu

Genetic tests and medication response: FDA announces collaborative review of scientific evidence

USA - February 27 2020 FDA announced the introduction of a collaboration between the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and…

Susan D. Tiedy-Stevenson, Erkang Ai, Randy Prebula

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, Robert Church, Mike Druckman, William F. Ferreira, David M. Fox, Heidi Gertner, Dr. Rachel Gribben, 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

Clarifying clinical decision support: FDA overhauls guidance to focus on risk

USA - October 3 2019 On 27 September 2019 the U.S. Food and Drug Administration (FDA or the Agency) released the draft guidance entitled "Clinical Decision Support…

Susan D. Tiedy-Stevenson, Lina R. Kontos, Suzanne Levy Friedman, Tammi Tram Huynh, Yarmela Pavlovic

FDA issues draft guidance on providing regulatory submissions in electronic format

USA - September 26 2019 On 26 September 2019 the U.S. Food and Drug Administration (FDA or the Agency) published a draft guidance document entitled "Providing Regulatory…

Randy Prebula