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 +4 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
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 +3 more sources
Postmarketing surveillance study of a non-chlorofluorocarbon inhaler [PDF]
BMJ, 1999 Editor—The study by Ayres et al may have been selectively designed to promote a product as safe; they endorse it as conforming to unpublished guidelines for postmarketing surveillance studies under safety assessment of marketed medicines.1 Withdrawals from the study are mainly for reasons “not related to safety,” and the withdrawal rate of the product ...
M G Bamber +6 more
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Stepwise approach of development of dermo‐cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance [PDF]
Journal of the European Academy of Dermatology and Venereology, 2019 AbstractBackground/objectivesPaediatric skin, considered sensitive, and infant skin, more susceptible to percutaneous toxicity, require specially formulated cosmetic products. As recently shown, early use of emollients in infants “at risk” of developing atopic dermatitis has shown controversial results in reducing the incidence of atopic dermatitis ...
V. Ribet +5 more
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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 ...
openaire +3 more sources
Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China
Journal of Epidemiology, 2014 China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China.
Weizhong Yang +5 more
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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
The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. [PDF]
, 2016 PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were ...
Andrews, Elizabeth B +6 more
core +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