Results 21 to 30 of about 12,493 (244)
Orphanet Journal of Rare Diseases, 2022 Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan
Min Fan +10 more
doaj +1 more source
Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance. [PDF]
PLoS ONE, 2010 BackgroundPostmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect ...
Joseph R Egger +4 more
doaj +1 more source
Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
, 2014 A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Post-marketing stability surveillance: Amoxicillin
South African Family Practice, 2006 Background: To ensure the successful treatment of infectious disease using antimicrobial therapy, a sufficient concentration of the stable, active drug is required at the site of infection.
K.K. Naidoo +5 more
doaj +1 more source
Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]
, 2010 Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y. +3 more
core +1 more source
Neonatal Safety Information Reported to the FDA During Drug Development Studies. [PDF]
, 2018 BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates
Ariagno, Ron +8 more
core +3 more sources
Therapeutic Advances in Drug Safety, 2019 Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj +5 more
doaj +1 more source
Pharmaceuticals, 2023 Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of ...
Valerio Ciccone +3 more
doaj +1 more source
Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study [PDF]
Intestinal Research, 2021 Background/Aims Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’
Tadakazu Hisamatsu +8 more
doaj +1 more source