Results 231 to 240 of about 931,588 (304)

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +1 more source

A comparative analysis of food retail policy landscape in four Southeast Asian countries. [PDF]

open access: yesLancet Reg Health Southeast Asia
Phulkerd S   +11 more
europepmc   +1 more source

Setting up mother–infant pair lactation studies with biobanking for research according to regulatory requirements

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Within the ConcePTION project we set out to design two mother–infant pair studies collecting breast milk and plasma from the mother and plasma from the infant (for metformin and prednisolone) in order to demonstrate the premises and conditions for investigating potential drug transfer in association with breastfeeding.
Mats Hansson   +11 more
wiley   +1 more source

Age‐related differences in hydroxychloroquine‐associated adverse events: A pharmacovigilance study based on the FDA Adverse Event Reporting System

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This real‐world pharmacovigilance study utilizes FDA Adverse Event Reporting System (FAERS) data (2004–2024) to characterize age‐related disparities in hydroxychloroquine (HCQ)‐associated adverse events (AEs), addressing gaps in age‐stratified risk assessment. Methods Disproportionality analysis (reporting odds ratios, RORs) and parametric Weibull
Guanghan Sun   +4 more
wiley   +1 more source

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Extreme Risk Protection Orders and Firearm and Nonfirearm Suicides in the US.

open access: yesJAMA Health Forum
Brown TT, Kaplan MS, Yan Z, Xiao Y.
europepmc   +1 more source

Paths of legal recognition of genetic counselors in Canada: A framework for action. [PDF]

open access: yesJ Genet Couns
Patrinos D   +5 more
europepmc   +1 more source

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