Regulatory Science in Neonates: A Framework That Supports Evidence-Based Drug Therapy.
Sign Up to like & getrecommendations! Published in 2017 at "JAMA pediatrics"
DOI: 10.1001/jamapediatrics.2017.1360
Abstract: Overview The International Neonatal Consortium (INC) integrates global stakeholders to promote clinical drug development for neonates.1 The INC focuses on generalizable methods for using data to support claims that a drug is safe and efficacious… read more here.
Keywords: medicine; regulatory science; science; drug ... See more keywords
Cigarette Management System: An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research
Sign Up to like & getrecommendations! Published in 2018 at "Contemporary Clinical Trials Communications"
DOI: 10.1016/j.conctc.2018.05.006
Abstract: Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science… read more here.
Keywords: tobacco; research; regulatory science; investigational tobacco ... See more keywords
Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications
Sign Up to like & getrecommendations! Published in 2021 at "Chinese Medicine"
DOI: 10.1186/s13020-021-00433-2
Abstract: Background The National Medical Products Administration (NMPA) in China has set to advance the regulatory capacity of traditional Chinese medicines (TCMs) with the adoption of regulatory science (RS). However, the priority of actions at the… read more here.
Keywords: medicine; regulatory science; traditional chinese; tcms ... See more keywords
Communicating to and engaging with the public in regulatory science[Link]
Sign Up to like & getrecommendations! Published in 2019 at "EFSA Journal"
DOI: 10.2903/j.efsa.2019.e170717
Abstract: Abstract This paper presents selected highlights from the ‘Engaging with society’ session of EFSA's third Scientific Conference ‘Science, Food and Society’ (Parma, Italy, 18–21 September 2018). The social dimension for scientific advisory bodies largely concerns… read more here.
Keywords: engaging public; regulatory science; science link; science ... See more keywords
Huntington's Disease Regulatory Science Consortium: Accelerating Medical Product Development.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Huntington's disease"
DOI: 10.3233/jhd-220533
Abstract: Huntington's disease (HD) is a devastating neurodegenerative disorder that urgently needs disease-modifying therapeutics. To this end, collaboration to standardize clinical research practices in the field and drive progress in addressing drug development challenges is paramount.… read more here.
Keywords: huntington disease; disease; consortium; regulatory science ... See more keywords
New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science
Sign Up to like & getrecommendations! Published in 2023 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2022.1109541
Abstract: The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary… read more here.
Keywords: science; division applied; fda division; regulatory science ... See more keywords
Editorial: Reviews in: regulatory science
Sign Up to like & getrecommendations! Published in 2023 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2023.1206753
Abstract: COPYRIGHT © 2023 Kerpel-Fronius, Stoyanova-Beninska, Giannuzzi and Sun. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted,… read more here.
Keywords: editorial reviews; regulatory science; reviews regulatory;