Results 1 to 10 of about 731,751 (310)

Food and Drug Administration

British medical journal, 2007
More independent resources and alternative ways to identify adverse events are ...
Linda R Horton
semanticscholar   +1 more source

Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration

PLoS Medicine, 2008
Background Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance.
I. Kirsch, B. Deacon, Tania B. Huedo-Medina, A. Scoboria, T. Moore, Blair T. Johnson   +5 more
semanticscholar   +1 more source

Outpatient Fluoroquinolone Prescription Fills in the United States, 2014 to 2020: Assessing the Impact of Food and Drug Administration Safety Warnings

Antimicrobial Agents and Chemotherapy, 2021
The impact of United States Food and Drug Administration (FDA) safety warnings on outpatient fluoroquinolone use is unclear. Annual changes in outpatient ciprofloxacin, levofloxacin, and moxifloxacin prescription fills (IQVIA National Prescription Audit ...
Deanna J. Buehrle, M. Wagener, C. Clancy
semanticscholar   +1 more source

Pharmacokinetic Drug-Drug Interactions with Drugs Approved by the US Food and Drug Administration in 2020: Mechanistic Understanding and Clinical Recommendations

Drug Metabolism And Disposition, 2021
Drug-drug interaction (DDI) data for small molecular drugs approved by the US Food and Drug Administration in 2020 (N = 40) were analyzed using the University of Washington Drug Interaction Database.
Jingjing Yu, Yan Wang, I. Ragueneau-Majlessi   +2 more
semanticscholar   +1 more source

The role of PD-L1 expression as a predictive biomarker: an analysis of all US Food and Drug Administration (FDA) approvals of immune checkpoint inhibitors

Journal of Immunotherapy for Cancer, 2019
The development of immune checkpoint inhibitors has changed the treatment paradigm for advanced cancers across many tumor types. Despite encouraging and sometimes durable responses in a subset of patients, most patients do not respond.
A. Davis, V. Patel
semanticscholar   +1 more source

Health Claims About Cannabidiol Products: A Retrospective Analysis of U.S. Food and Drug Administration Warning Letters from 2015 to 2019

Cannabis and Cannabinoid Research, 2021
Background: Cannabidiol (CBD) products are increasingly available to consumers in the United States and are subject to regulation by the U.S. Food and Drug Administration (FDA).
Kimberly G. Wagoner, A. Lazard, E. Romero-Sandoval, B. Reboussin   +3 more
semanticscholar   +1 more source

A COVID‐19‐ready public health surveillance system: The Food and Drug Administration's Sentinel System

Pharmacoepidemiology and Drug Safety, 2021
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical product safety.
N. Cocoros, C. Fuller, S. Adimadhyam, R. Ball, Jeffrey S. Brown, G. D. Dal Pan, Sheryl A. Kluberg, V. Lo Re, J. Maro, M. Nguyen, Robert Orr, Dianne Paraoan, J. Perlin, R. Poland, Meighan Rogers Driscoll, K. Sands, S. Toh, W. K. Yih, R. Platt, Catherine Grace Sarah K. Wei Brian Silvia Danijela Corinne Corey Chai Dutcher Hua Kit Perez‐Vilar Stojanovic , Catherine Corey, Grace Chai, S. Dutcher, Wei Hua, Brian Kit, Silvia Perez-Vilar, D. Stojanovic, Corinne Woods   +27 more
semanticscholar   +1 more source

Ten‐Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs

Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease, 2020
Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals.
M. Khan, Izza Shahid, T. Siddiqi, Safi U. Khan, Haider J. Warraich, S. Greene, J. Butler, E. Michos   +7 more
semanticscholar   +1 more source

Global COVID‐19 pandemic and reporting behavior ‐ An analysis of the Food and Drug Administration adverse events reporting system

Pharmacoepidemiology and Drug Safety, 2021
To describe the characteristics of adverse event reporting in the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS) before and after the outbreak of the COVID‐19 pandemic.
M. Dörks, K. Jobski, F. Hoffmann, Antonios Douros   +3 more
semanticscholar   +1 more source

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

JAMA Network Open, 2020
Key Points Question Have the number and characteristics of pivotal efficacy trials supporting US Food and Drug Administration approval of new drugs and biologics changed during the past 3 decades?
A. Zhang, Jeremy Puthumana, Nicholas Downing, N. Shah, H. Krumholz, J. Ross   +5 more
semanticscholar   +1 more source