Results 301 to 310 of about 743,931 (363)

United States Food and Drug Administration Regulation of Gene and Cell Therapies.

Advances in Experimental Medicine and Biology, 2015
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes ...
A. Bailey, J. Arcidiacono, K. Benton, Z. Taraporewala, Steve O Winitsky   +4 more
semanticscholar   +4 more sources

Drug‐Associated Acute Kidney Injury Identified in the United States Food and Drug Administration Adverse Event Reporting System Database

Pharmacotherapy, 2018
Acute kidney injury (AKI) is a common condition associated with both short‐term and long‐term consequences including dialysis, chronic kidney disease, and mortality.
H. Welch, J. Kellum, S. Kane‐Gill
semanticscholar   +1 more source

Oncology drug development: United States Food and Drug Administration perspective

Critical Reviews in Oncology/Hematology, 2002
The Food and Drug Administration (FDA) in the United States has multiple roles. The primary responsibilities for oncology drug products are the supervision of clinical research, the evaluation of marketing claims for new and previously approved drugs, the granting of exclusive marketing licenses for approved claims, and the monitoring of post-marketing
Steven Hirschfeld, Richard Pazdur
openaire   +3 more sources

Analysis of adverse events with sclerosants reported to the United States Food and Drug Administration

Phlebology: The Journal of Venous Disease, 2022
Objectives To analyze adverse events (AEs) related to sclerosants reported through the Federal Adverse Event Reporting System (FAERS). Methods We queried the FAERS database for all cases associated with sclerosants. Reports were analyzed and stratified based on severity of cases and patient death.
Christopher N Nguyen, Quoc-Bao D Nguyen, Sirunya Silapunt   +2 more
openaire   +2 more sources

The United States Food and Drug Administration’s Risk Management Framework

Drug Information Journal, 2002
In response to criticism that under the Prescription Drug User Fee Act, the United States Food and Drug Administration was endangering public health by shortening the review and approval process for medical products, former Food and Drug Administration Commissioner Jane Henney appointed a task force to evaluate the effectiveness of the Food and Drug ...
Gina Steidle, Shawn E. Hodges
openaire   +2 more sources

Retrospective analysis of adverse events with dupilumab reported to the United States Food and Drug Administration

Journal of the American Academy of Dermatology, 2021
Atopic dermatitis (AD) is one of the most common inflammatory skin diseases and has aesthetic, physical, and emotional-social sequelae when left untreated.To classify the most common adverse reactions associated with dupilumab treatment in patients with AD.The United States Food and Drug Administration Adverse Event Reporting (FAERS) database was ...
Joseph L. Jorizzo, Joseph L. Jorizzo, Yu Wang   +2 more
openaire   +3 more sources

Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials.

Journal of Neurosurgery : Spine, 2012
OBJECT There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up ...
C. Upadhyaya, Jau-Ching Wu, G. Trost, R. Haid, V. Traynelis, B. Tay, D. Coric, P. Mummaneni   +7 more
semanticscholar   +1 more source

What's new on nutrition labeling at the United States Food and Drug Administration?

Journal of Food Composition and Analysis, 2003
Abstract The manuscript provides an overview of food labeling activities of the United States (USA) Food and Drug Administration (FDA). Highlights include: • FDA will proceed with final rulemaking on trans fatty acid labeling after review of the National Academy of Sciences (NAS) Macronutrient Report.
Mary Bender Brandt, Lori A. LeGault
openaire   +2 more sources

United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

Journal of Pharmacy and Science, 2014
The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry.
Saeed R. Khan, R. Kona, P. Faustino, Abhay Gupta, Jeb S Taylor, D. A. Porter, M. Khan   +6 more
semanticscholar   +1 more source

U.S. Food and Drug Administration Drug Approval

Obstetrics & Gynecology, 2010
The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development.
Durlin E. Hickok, Barbara L. Powers, Deborah A. Wing   +2 more
openaire   +2 more sources