Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events. [PDF]
Drugs Real World OutcomesThere is a growing interest in products featuring hemp extracts and a demand for more data regarding their safety. To date, there is a paucity of published data on the safety of these products.A retrospective analysis of postmarketing surveillance data collected in the United States on full spectrum hemp extract (FSHE) products manufactured by ...
Kingsbury CM, Zvorsky I, Spelman K.
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Postmarketing Surveillance for "Modified-Risk" Tobacco Products [PDF]
Nicotine & Tobacco Research, 2011 The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have "modified-risk" for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of ...
Richard J. O’Connor
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Postmarketing surveillance Is not used to promote products [PDF]
BMJ, 1994 EDITOR, - Simon Voss and Fiona Harris's concerns about postmarketing surveillance need to be challenged.1 Without producing any evidence the authors imply deceit by pharmaceutical companies in three ways: firstly, by using “so called” independent research companies that do not acknowledge their link with the pharmaceutical companies; secondly, by using
M Vandenburg, W H Inman
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Enhancing Postmarketing Surveillance of Medical Products With Large Language Models
JAMA Network OpenImportanceThe Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA advisory committee meetings, and other regulatory decisions.
Michael E, Matheny +12 more
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National Pharmacovigilance Assessment of Oral Adverse Events Following COVID-19 Vaccination in Germany (2020-2023) [PDF]
International Dental JournalObjectives: Pharmacovigilance efforts for COVID-19 vaccines have largely focused on severe adverse events (AEs), while nonserious, yet distressing, AEs, such as oral AEs, remain underexamined. This study aimed to analyse oral AE reporting patterns in the
Abanoub Riad
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Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend. [PDF]
Clin Pharmacol TherSeveral regulatory initiatives have been made to clarify the acceptability and requirements of real‐world data and real‐world evidence (RWD/E) for the benefit/risk assessment of new medical products in Japan. The objectives of this review were to characterize the use of RWD/E in regulatory applications of new medical products and to describe the ...
Okami S, Shimotsumagari K, Sadatsuki Y.
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Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance [PDF]
Intestinal Research, 2022 Background/Aims Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in ...
Shiro Nakamura +6 more
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Real-World Outcomes of Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Results From the Final Analysis of Postmarketing Surveillance. [PDF]
Cancer MedABSTRACT Background Avelumab maintenance therapy was approved in Japan in February 2021 for the treatment of curatively unresectable urothelial carcinoma (UC) that has not progressed after prior chemotherapy based on results from the JAVELIN Bladder 100 phase 3 trial.
Kikuchi E +7 more
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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
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
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