Results 161 to 170 of about 27,419 (207)

Evaluation of the Relative Abuse of an OROS Extended-release Hydromorphone HCI Product

The Clinical Journal of Pain, 2018
Objective: Formulating prescription opioids to limit abuse remains a priority. OROS extended-release (ER) hydromorphone HCl (EXALGO) may have lower abuse potential than many other opioid products. Three postmarketing studies of the relative abuse liability of OROS hydromorphone ER were conducted.
Butler, Stephen F., McNaughton, Emily C., Black, Ryan A., Cassidy, Theresa A   +3 more
semanticscholar   +5 more sources

Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics

Drug Safety, 2023
Introduction Postmarketing drug safety surveillance research has focused on the product-patient interaction as the primary source of variability in clinical outcomes.
J. Wilde, S. Springs, J. Wolfrum, R. Levi   +3 more
semanticscholar   +2 more sources

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Photosensitivity associated with anaplastic lymphoma kinase inhibitors: A review of postmarketing cases reported to FDA and published in the literature

Photodermatology, Photoimmunology & Photomedicine, 2022
To the Editor, The U.S. Food and Drug Administration (FDA) has approved five anaplastic lymphoma kinase (ALK) inhibitors (i.e., crizotinib, ceritinib, alectinib, brigatinib, lorlatinib) since 2011 to treat ALKpositive, metastatic nonsmall cell lung ...
Connie Cheng, Afrouz Nayernama, S. Jones, Melissa Reyes   +3 more
semanticscholar   +1 more source

The First 4 Years of Postmarketing Safety Surveillance Related to the MitraClip Device: A United States Food and Drug Administration MAUDE Experience.

The Journal of invasive cardiology, 2020
OBJECTIVE The MitraClip (Abbott) is a commercially available device to perform percutaneous transcatheter mitral valve repair (TMVR) for patients with symptomatic mitral regurgitation (MR).
Chetaj A. Mahabir, E. DeFilippis, S. Aggarwal, A. Bath, Arman Qamar, Nilay K. Patel, Andrew M. Goldsweig, M. Vaduganathan   +7 more
semanticscholar   +1 more source

Active Surveillance of Postmarket Medical Product Safety in the Federal Partners' Collaboration

Medical Care, 2012
After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they ...
Melissa A, Robb, Judith A, Racoosin, Chris, Worrall, Summer, Chapman, Trinka, Coster, Francesca E, Cunningham   +5 more
openaire   +2 more sources

Effectiveness and Safety of Guselkumab in Patients With Moderate‐to‐Severe Plaque Psoriasis in Real‐World Practice in Korea: A Prospective, Multicenter, Observational, Postmarketing Surveillance Study

Journal of dermatology (Print)
Clinical trials have demonstrated the efficacy and safety of guselkumab in patients with moderate‐to‐severe plaque psoriasis. Real‐world evidence for guselkumab in Korea is needed to establish drug safety and effectiveness under real‐world practice in ...
B. Shin, Miri Kim, Moo Kyu Suh, Young Bok Lee, S. Youn, Ji Yeoun Lee, C. Kim, Ga-Young Lee, Sang Wook Son, K. Kim, Jihye An, Youngdoe Kim, Kwang Joong Kim, Dong Hyun Kim   +13 more
semanticscholar   +1 more source

Complementary hypotheses in safety surveillance

, 2020
Postmarketing safety surveillance studies address two actionable questions: (1) Is the test product riskier than a standard? (2) Is the risk associated with the test product within some tolerable margin by comparison to the standard?
A. Walker
semanticscholar   +1 more source

Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectivesThis article is one of a selection of papers published in this special issue (part 1 of 2) on the Safety and Efficacy of Natural Health Products.

Canadian Journal of Physiology and Pharmacology, 2007
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP–drug interactions, or product quality.
openaire   +1 more source

Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectives.

Canadian journal of physiology and pharmacology, 2008
Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP-drug interactions, or product quality. High consumer use and limited safety and efficacy data from human
openaire   +1 more source

Effectiveness and Safety of Matrix-Associated Autologous Chondrocyte Implantation for the Treatment of Articular Cartilage Defects: A Real-World Data Analysis in Japan

American Journal of Sports Medicine
Background: The effectiveness and safety of matrix-associated autologous chondrocyte implantation with an autologous periosteal flap (pMACI) remain unclear.
Yuji Uchio, Ryosuke Kuroda, Yasuo Niki, K. Sugawara, Yasuyuki Ishibashi   +4 more
semanticscholar   +1 more source