Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration [PDF]
Vivek Reddy Murthannagari +4 more
openalex +1 more source
Objective We aimed to identify unique disease trajectories within rheumatoid arthritis–associated interstitial lung disease (RA‐ILD) based on longitudinal forced vital capacity (FVC) values and their associated clinical outcomes. Methods We performed a cohort study of RA‐ILD within the Veterans Health Administration from 1999 to 2021.
Bryant R. England +9 more
wiley +1 more source
Gadolinium-enhanced cardiovascular magnetic resonance: administered dose in relationship to united states food and drug administration (FDA) guidelines [PDF]
Marcelo Souto Nacif +3 more
openalex +1 more source
Long‐Term Opioids in Gout: A Matched Cohort Study From the Veterans Health Administration
Objective Though used frequently to treat flare, risk of long‐term opioid exposure in gout has not been well defined. In this study, we examined the hypothesis that people with gout are more likely than individuals without gout to be prescribed long‐term opioids over time.
Lindsay N. Helget +7 more
wiley +1 more source
Objectives There is growing interest in evaluating new strategies to delay or prevent post‐traumatic osteoarthritis (PTOA) in individuals who have sustained anterior cruciate ligament (ACL) injury. This study sought to determine characteristics of potential treatments that are acceptable to patients with ACL injury.
Kevin Kennedy +9 more
wiley +1 more source
Intraspinal steroids: history, efficacy, accidentality, and controversy with review of United States Food and Drug Administration reports [PDF]
Dewey A. Nelson
openalex +1 more source
Objective Ultrasound (US) has been proposed as a potential tool for assessing skin fibrosis in systemic sclerosis (SSc). However, a large‐scale comparison of US‐based assessment with histologic markers of skin fibrosis has not been reported. We evaluated US‐based skin assessments for their face validity (differentiation between involved SSc and healthy
Ruhani Desai +12 more
wiley +1 more source
P84 Pediatric oncology studies triggered by the united states (US) food and drug administration (FDA) and the european union (EU) european medicines agency (EMA) aim at labels, not at improved treatment. Some harm young patients by exposing them to substandard monotherapy instead of combination treatment [PDF]
Klaus Rose
openalex +1 more source
Objective This systematic review aimed to assess the diagnostic accuracy of algorithms used to identify rheumatoid arthritis and juvenile idiopathic arthritis in electronic health records. Methods We searched Medline, Embase, and Cochrane Central Register for Controlled Trials databases and included studies that validated case definitions against a ...
Constanza Saka‐Herrán +10 more
wiley +1 more source
Objective A patient‐centered approach for chronic disease management, including systemic lupus erythematosus (SLE), aligns treatment with patients’ values and preferences, leading to improved outcomes. This paper summarizes how patient experiences, perspectives, and priorities informed the American College of Rheumatology (ACR) 2024 Lupus Nephritis (LN)
Shivani Garg +20 more
wiley +1 more source

