Results 141 to 150 of about 159,613 (271)

Commercial Health Plan and Enrollee Out-of-Pocket Spending on Accelerated Approval Products in 2019.

JAMA Intern Med, 2023
Jazowski SA, Vaidya AU, Donohue JM, Dusetzina SB, Sachs RE.   +4 more
europepmc   +1 more source

Supplementary Table S3 from Real-World Clinical Oncology Outcomes Associated with the Accelerated Approval Pathway

Tu My To, Stacey Kowal, James D. Chambers, William B. Wong   +3 more
openalex   +1 more source

Knee Crepitus and Osteoarthritis Features in Young Adults Following Traumatic Knee Injury

Arthritis Care &Research, EarlyView.
Objective This study explored the association between knee crepitus and the presence, and worsening, of structural osteoarthritis features and self‐reported outcomes in young adults following traumatic knee injury. Methods One year following anterior cruciate ligament reconstruction (ACLR), 112 participants (41 female participants; median age 28 years ...
Jamon L. Couch, Brooke E. Patterson, Kay M. Crossley, Ali Guermazi, Matthew G. King, Danilo De Oliveira Silva, Jackie L. Whittaker, Michael A. Girdwood, Adam G. Culvenor   +8 more
wiley   +1 more source

Real-World Clinical Oncology Outcomes Associated with the Accelerated Approval Pathway. [PDF]

Cancer Res Commun
To TM, Kowal S, Chambers JD, Wong WB.
europepmc   +1 more source

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration [PDF]

, 2017
Huseyin Naci, Katelyn R. Smalley, Aaron S. Kesselheim   +2 more
openalex   +1 more source

Serum Soluble Mediator Signatures of Lupus Nephritis: Histologic Features and Response to Treatment

Arthritis Care &Research, EarlyView.
Objective Lupus nephritis (LN) management remains challenging, and novel noninvasive biomarkers are needed. This study quantified serum soluble mediators in the Accelerating Medicines Partnership (AMP) LN cohort to identify biomarkers of histologic features and treatment response.
Andrea Fava, Catriona A. Wagner, Carla J. Guthridge, Susan Macwana, Wade DeJager, Melissa E. Munroe, Peter Izmirly, H. Michael Belmont, Betty Diamond, Anne Davidson, Paul J. Utz, Michael H. Weisman, Philip M. Carlucci, Maria Dall'Era, Kenneth Kalunian, Chaim Putterman, Jennifer Anolik, Jennifer L. Barnas, David Wofsy, Diane Kamen, Richard A. Furie, Deepak A. Rao, the Accelerating Medicines Partnership Rheumatoid Arthritis and Systemic Lupus Erythematosus Network, Chun‐Hao Lee, Derek Fine, Manny Monroy‐Trujillo, Ummara Shah, Mariko Ishimori, Robert M. Clancy, Michael Belmont, Ming Wu, Nicole Bornkamp, Evan Der, Beatrice Goilav, Nicole Jordan, Daniel Schwartz, James Pullman, David Wofsy, Dawn Smilek, Patti Tosta, Matthias Kretzler, Celine C. Berthier, E. Steve Woodle, Dave Hildeman, Michael Brenner, Michelle Petri, Joel M. Guthridge, Jill Buyon, Judith A. James   +48 more
wiley   +1 more source

Clinical Conditions Associated With a High Antinuclear Antibody Titer in Individuals Without Autoimmune Disease

Arthritis Care &Research, EarlyView.
Objective Antinuclear antibodies (ANAs) are present at high titers in 2% of the general population, but their clinical significance in individuals without an autoimmune (AI) disease is not known. We tested the hypothesis that the presence of a high ANA titer in non‐AI conditions is associated with disease.
Matthew Chung, John P. Shelley, Gul Karakoc, John Still, Xiaodi Ruan, Jonathan Mosley, C. Michael Stein, Vivian K. Kawai   +7 more
wiley   +1 more source

Dual-Criterion Approach Incorporating Historical Information to Seek Accelerated Approval With Application in Time-to-Event Group Sequential Trials. [PDF]

Stat Med
Ratta M, Saint-Hilary G, Barboux V, Gasparini M, Skanji D, Mozgunov P.   +5 more
europepmc   +1 more source

Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US.

JAMA Intern Med, 2023
Jazowski SA, Vaidya AU, Donohue JM, Dusetzina SB, Sachs RE.   +4 more
europepmc   +1 more source

Use of real-world evidence to support regulatory decisions on medical devices in China and a unique opportunity to gain accelerated approval in "Boao Lecheng Pilot Zone". [PDF]

Cost Eff Resour Alloc, 2023
Li J, Liu L, Cao H, Yang M, Sun X.
europepmc   +1 more source