Zobrazeno 1 - 10
of 308
pro vyhledávání: '"Regulatory decision-making"'
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Since its commencement as part of the Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA) V in 2012, patient-focused drug development (PFDD) has become an integral part of the drug development paradigm. FDA encourages the de
Externí odkaz:
https://doaj.org/article/6b0d2edc02bd4ec89e8bc667e5fcc799
Autor:
Frontiers Production Office
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Externí odkaz:
https://doaj.org/article/9b1546b522754e6f9ef0a8dcb86bc34e
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Medicine regulators need to judge whether a drug’s favorable effects outweigh its unfavorable effects based on a dossier submitted by an applicant, such as a pharmaceutical company. Because scientific knowledge is inherently uncertain, regulators a
Externí odkaz:
https://doaj.org/article/de5da8ddadff4f3eacf6cd06570a7d93
Autor:
Philipp Cimiano, Ben Collins, Maria Carmela De Vuono, Thierry Escudier, Jürgen Gottowik, Matthias Hartung, Mathias Leddin, Bikalpa Neupane, Raul Rodriguez-Esteban, Ana Lucia Schmidt, Cornelius Starke-Knäusel, Maarten Voorhaar, Krzysztof Wieckowski
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Patients, life science industry and regulatory authorities are united in their goal to reduce the disease burden of patients by closing remaining unmet needs. Patients have, however, not always been systematically and consistently involved in the dru
Externí odkaz:
https://doaj.org/article/e5abb5d01e8e4320baa1e8a71fd224e8
Akademický článek
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Autor:
Leah Burns, Nadege Le Roux, Robert Kalesnik-Orszulak, Jennifer Christian, Jennifer Dudinak, Frank Rockhold, Sean Khozin, John O’Donnell
Publikováno v:
Frontiers in Medicine, Vol 10 (2023)
Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at the point-of-
Externí odkaz:
https://doaj.org/article/59f5a615a3cc4ad4a4348350b98223f5
Autor:
Catherine Lau, George Dranitsaris
Publikováno v:
Current Oncology, Vol 29, Iss 11, Pp 8031-8042 (2022)
Real-world evidence (RWE) is health and outcomes data generated from a patient’s journey through the health care system or disease process (i.e., real-world data). RWE is now having an increasingly important role in regulatory/reimbursement decisio
Externí odkaz:
https://doaj.org/article/95f71a882f544cbc8de7c405bd0d21fb
Akademický článek
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Autor:
Haruka Shida, Kazuhiro Kajiyama, Sono Sawada, Chieko Ishiguro, Mikiko Kubo, Ryota Kimura, Mai Hirano, Noriyuki Komiyama, Toyotaka Iguchi, Yukio Oniyama, Yoshiaki Uyama
Publikováno v:
Frontiers in Medicine, Vol 10 (2023)
The Pharmaceuticals and Medical Devices Agency (PMDA) has conducted many pharmacoepidemiological studies for postmarketing drug safety assessments based on real-world data from medical information databases. One of these databases is the National Dat
Externí odkaz:
https://doaj.org/article/ab7cb8b8c86647c585e7d163de6b27d1
Autor:
Ashley Jaksa, Patrick J. Arena, Kelvin K. W. Chan, Rami H. Ben-Joseph, Páll Jónsson, Ulka B. Campbell
Publikováno v:
Frontiers in Medicine, Vol 9 (2022)
Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Due to challenges in identifying high-quality and relevant RWD sources, rese
Externí odkaz:
https://doaj.org/article/26eb172ca3ad4da8aeae11e78d6660b7