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
semanticscholar +5 more sources
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.
europepmc +5 more sources
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
semanticscholar +4 more sources
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
openaire +4 more sources
Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study. [PDF]
J DermatolABSTRACT Apremilast is a phosphodiesterase 4 inhibitor approved for moderate to severe psoriasis in Japan. Apremilast significantly improved Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) both at 6 and 12 months in a previously published primary post‐surveillance study.
Ohtsuki M +8 more
europepmc +2 more sources
Safety of the Selective JAK1 Inhibitor Oclacitinib in Dogs. [PDF]
J Vet Pharmacol TherABSTRACT Apoquel(oclacitinib maleate) as a film‐coated tablet, a selective Janus kinase (JAK)1 inhibitor, was approved by the United States Food and Drug Administration (FDA) in 2013 for the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Nederveld SM, Krautmann MJ, Mitchell J.
europepmc +2 more sources
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 +5 more sources
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
doaj +1 more source
Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance [PDF]
Diabetes & Metabolism Journal, 2023 Background To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.
Jun Sung Moon +12 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