Zobrazeno 1 - 10
of 33
pro vyhledávání: '"Frances J. Richmond"'
Autor:
Frances J. Richmond, Grzegorz Zapotoczny, Brian Green, Sowmya Lokappa, Katy Rudnick, Juan Espinoza, the ICRS-CTIP Collaborative for Regulatory Research
Publikováno v:
Journal of Clinical and Translational Science, Vol 6 (2022)
Abstract Background: Startup companies in the healthcare sector often fail because they lack sufficient entrepreneurial, regulatory, and business development expertise. Maturity models provide useful frameworks to assess the state of business elemen
Externí odkaz:
https://doaj.org/article/6f4c52397ad748938f51838066f62923
Publikováno v:
Alzheimer’s & Dementia: Translational Research & Clinical Interventions, Vol 8, Iss 1, Pp n/a-n/a (2022)
Abstract Introduction The U.S. Food and Drug Administration (FDA)'s guidances help describe the agency's current thinking on regulatory issues and serve as a means of informal policymaking that is non‐binding. This study examines the impact of two
Externí odkaz:
https://doaj.org/article/ccfa05ce0c8e46e28a0c63e0fded3f22
Autor:
Gerald E. Loeb, Frances J. Richmond
Publikováno v:
Frontiers in Robotics and AI, Vol 8 (2021)
Academic researchers concentrate on the scientific and technological feasibility of novel treatments. Investors and commercial partners, however, understand that success depends even more on strategies for regulatory approval, reimbursement, marketin
Externí odkaz:
https://doaj.org/article/828d8d936c50411d96267714bf158f01
Autor:
Sherry Farrugia, Leanne L. West, Allison Komiyama, Kevin O. Maher, Dawn M. Wolff, Sharief Taraman, Michael O'Donnell, Jon Brophy, Srinivasan Suresh, Terence D. Sanger, Christopher M. Horvat, James Wall, Usha Thekkedath, Omkar Kulkarni, Robert J. Levy, Kolaleh Eskandanian, Nadine B. Afari, Frances J. Richmond, Michael R. Harrison, Tiffani Ghere, Shreim Samir, Kara Toman, George Tolomiczenko, Anthony C. Chang, Mustafa H. Kabeer, Claudia K. Hoyen, William Feaster, Brent A. Dethlefs, Charlette Stallworth, Jessica Richter, Krista Nelson, Todd A. Ponsky, Michael Billig, Debra Beauregard, Juan Espinoza, Chester Koh, Shuvo Roy
Publikováno v:
IEEE Journal of Translational Engineering in Health and Medicine
IEEE Journal of Translational Engineering in Health and Medicine, Vol 9, Pp 1-5 (2021)
IEEE Journal of Translational Engineering in Health and Medicine, Vol 9, Pp 1-5 (2021)
Objective: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. Methods: On Au
Publikováno v:
Ethiopian journal of health sciences. 32(5)
Decades ago, the United Nations declared that access to essential medicines was a key element of universal human rights. Accordingly, member states have been striving to address this issue through strategic policies and programs. Strengthening local
Publikováno v:
Therapeutic Innovation & Regulatory Science. 54:947-952
Background Talent acquisition in regulatory affairs has been a continuing challenge now exaggerated by demographic shifts and expansion of regulatory requirements nationally and globally. Methods Survey and interview methods were used to provide info
Autor:
Clare Elser, Frances J. Richmond
Publikováno v:
Therapeutic Innovation & Regulatory Science. 53:354-363
Some international regulatory agencies require that companies develop a validation master plan (VMP) to govern their validation activities, but such a plan is not an explicit requirement of US regulations. This paper examines the progress that US pha
Autor:
Amy S. Martinez, Laurel M. Fisher, Frances J. Richmond, Laurie S. Eisenberg, Eric P. Wilkinson, Mark D. Krieger
Publikováno v:
Therapeutic Innovation & Regulatory Science. 52:669-679
BACKGROUND/AIMS: Children with congenital cochleovestibular abnormalities associated with profound hearing loss have few treatment options if cochlear implantation does not yield benefit. An alternative is the auditory brainstem implant (ABI). Regula
Publikováno v:
Biopreservation and biobanking. 17(5)
Academic biobanks face challenges that call for continuity and disaster planning. However, current regulations do not require such planning, so it is unclear if and how biobanks have prepared themselves to deal with future crises. This exploratory st
Autor:
Lilit Aladadyan, Susan Bain, Paul Beninger, Roger Clemens, Mary Ellen Cosenza, Daniela Drago, David A. Dzanis, Shayesteh Fürst-Ladani, Nanae Hangai, Michael Jamieson, Christy Kadharmestan, Michael M. McGuffin, Eunjoo Pacifici, Nancy Pire-Smerkanich, Frances J. Richmond, Jonathan M. Samet, Sai S. Tatavarty, Simone E. Turnbull, James William Woodlee, Anthony L. Young
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5780cfa03a65c50414573dc85e59449a
https://doi.org/10.1016/b978-0-12-811155-0.00016-8
https://doi.org/10.1016/b978-0-12-811155-0.00016-8