Results 51 to 60 of about 13,126 (223)

Postmarket evaluation of breakthrough technologies

open access: yesAmerican Heart Journal, 2008
Cardiovascular procedures performed in the United States have more than tripled in the last decade, a trend that is expected to continue with the aging of the population, coupled with epidemics of obesity and diabetes mellitus. Helping to drive this increase are new medical devices that address conditions previously treated by medication alone. Many of
Duke Clinical Research Institute and Duke University Medical Center, Durham, NC ( host institution )   +11 more
openaire   +3 more sources

A case report on the long‐term use of teduglutide in a pediatric patient with short bowel syndrome

open access: yesNutrition in Clinical Practice, EarlyView.
Abstract Short bowel syndrome (SBS) is the leading cause of intestinal failure, frequently necessitating long‐term parenteral nutrition (PN). Teduglutide (TED), a glucagon‐like peptide‐2 analog, has demonstrated efficacy in reducing PN dependence in both adults and children. However, long‐term data in pediatric populations remain limited.
Tsuyoshi Sakurai   +8 more
wiley   +1 more source

SAFETY PROFILE OF OCRIPLASMIN FOR SYMPTOMATIC VITREOMACULAR ADHESION: A Comprehensive Analysis of Premarketing and Postmarketing Experiences

open access: yes, 2015
After the recent approval of ocriplasmin by the Food and Drug Administration, postmarketing safety concerns have been raised by the vitreoretinal community. The American Society of Retina Specialists Therapeutic Surveillance Committee was commissioned to
Chung, Mina M   +7 more
core   +1 more source

Hallucinatory Side Effects of ADHD Drugs

open access: yesPediatric Neurology Briefs, 2009
Clinical trial and postmarketing surveillance data for drugs used in treatment of attention deficit hyperactivity disorder were analyzed to determine the frequency of hallucinations and other psychotic side effects, in a study at the US Food and Drug ...
J Gordon Millichap
doaj   +1 more source

A critical appraisal of the safety of bedinvetmab (Beransa), a canine antinerve growth factor monoclonal antibody

open access: yesAustralian Veterinary Journal, EarlyView.
Clinical scenario Canine osteoarthritis (OA) is a degenerative joint disease and is one of the most common chronic conditions in dogs and other species. The management of OA remains a longstanding focus in veterinary medicine. Traditionally, nonsteroidal anti‐inflammatory drugs (NSAIDs) have been the first‐line treatment option for canine OA. Recently,
X Yang, P Macarthur
wiley   +1 more source

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study

open access: yes, 2017
International audienceObjectives: To characterise postmarketing studies for drugs that were newly approved by the US Food and Drug Administration and the European Medicines Agency.Design and setting: Cross-sectional analysis of postmarketing studies ...
Zeitoun, Jean-David   +7 more
core   +3 more sources

Safety and Effectiveness of Glecaprevir/Pibrentasvir in Children and Adolescents With Chronic Hepatitis C: Reports From All‐Case Post‐Marketing Surveillance in Japan

open access: yesHepatology Research, EarlyView.
ABSTRACT Aim The aim of this all‐case post‐marketing study was to evaluate the real‐world safety and effectiveness in all children and adolescents with chronic hepatitis C with or without compensated cirrhosis treated with glecaprevir/pibrentasvir (G/P) in Japan. Methods This prospective, observational post‐marketing surveillance study was conducted at
Tatsuki Mizuochi   +6 more
wiley   +1 more source

Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis

open access: yesSexual Medicine, 2020
Background: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for ...
Alexander W. Pastuszak, MD, PhD   +2 more
doaj   +1 more source

Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines on the Use of Small Molecules and IL‐23 p19 Inhibitors in Ulcerative Colitis and Crohn's Disease

open access: yesJournal of Gastroenterology and Hepatology, EarlyView.
ABSTRACT Ulcerative colitis (UC) and Crohn's disease (CD) are increasingly prevalent in the Asia Pacific region, necessitating updated, region‐specific guidance on advanced therapies. Targeted small molecule agents, such as filgotinib, tofacitinib, upadacitinib, etrasimod, and ozanimod; and the IL‐23 p19 inhibitors (guselkumab, mirikizumab ...
Choon Jin Ooi   +34 more
wiley   +1 more source

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