Results 231 to 240 of about 2,837,325 (315)

Legal Financial Obligations: An Understudied Public Health Exposure. [PDF]

Am J Prev Med
Lindenfeld Z, Rouhani S.
europepmc   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Economic and econometric methods to measure the illicit tobacco trade: A scoping review. [PDF]

PLOS Glob Public Health
Phyo PP, Walker N, Ao BT, Sbai E, Bullen C.   +4 more
europepmc   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

How food regulations help or hinder the implementation of policies to promote healthy population diets: a review of food regulations in the Western Pacific Region. [PDF]

Public Health Nutr
Fries K, Backholer K, Jones A, Sing F, Reeve E.   +4 more
europepmc   +1 more source

Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact

British Journal of Clinical Pharmacology, EarlyView.
This systematic literature review aimed to identify and characterize existing interventions designed to empower citizens to spontaneously report adverse drug reactions (ADRs) and to determine which interventions have been shown to be the most effective internationally. The research question was structured using the PICO framework.
Margarida Perdigão, Ana Margarida Advinha, Manuel José Lopes, Sofia de Oliveira Martins   +3 more
wiley   +1 more source

Artificial intelligence translation in healthcare: an urgent call for evidence-informed policy frameworks. [PDF]

BMJ Health Care Inform
Anyaegbuna C, Steele N, Liang AS, Ma SP, Lopez I, Chilukuri N, Patel K, Schulman K, Chen JH.   +8 more
europepmc   +1 more source

Digital diagnostics, biomarkers and therapeutics in an evolving healthcare system: From promise to practice

British Journal of Clinical Pharmacology, EarlyView.
Abstract Health care is shifting towards a digital‐guided system, integrating digital diagnostics, biomarkers and therapeutics in many care pathways. However, despite rapid technological advancement and preliminary adoption accelerated by the COVID‐19 pandemic, a significant implementation gap persists. This narrative review explores the causes of this
Mees H. P. Stoop, Gertjan J. A. Driessen, Adam F. Cohen, Matthijs D. Kruizinga   +3 more
wiley   +1 more source

Privacy Policy Compliance of Mobile Sports and Health Apps in China: Scale Development, Data Analysis, and Prospects for Regulatory Reform. [PDF]

JMIR Mhealth Uhealth
Guo R, Chen F.
europepmc   +1 more source

Legal & policy recommendations

Result of task 5.3. Propositions for legal framework and sustainable business international with national options with regard to at least two pilots and within each innovation cluster. Early on, SCALE partners will liaise with the Commissions DG’S, industry task forces & STF sub-groups on key policy issues, e.g. data availability.
openaire   +1 more source