Results 21 to 30 of about 4,926,176 (337)

Review time of oncology drugs and its underlying factors: an exploration in China

Frontiers in Pharmacology, 2023
Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed.Methods: We ...
Xingyue Zhu, Bao Liu
doaj   +1 more source

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

European Journal of Health Economics, 2023
Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track ...
D. Michaeli, T. Michaeli, S. Albers, Tobias Boch, J. Michaeli   +4 more
semanticscholar   +1 more source

Association Between Food and Drug Administration Approval and Disparities in Immunotherapy Use Among Patients With Cancer in the US

JAMA Network Open, 2022
Key Points Question Is drug approval by the Food and Drug Administration (FDA) associated with a reduction in disparities in novel cancer treatment use among patients with cancer in the US?
T. Ermer, M. Canavan, R. Maduka, Andrew X. Li, Michelle C Salazar, M. Kaminski, M. Pichert, P. Zhan, Vincent Mase, H. Kluger, D. Boffa   +10 more
semanticscholar   +1 more source

Pharmacists’ Knowledge and Perceptions of FDA Approval Standards and the Breakthrough Therapy Designation

Pharmacy, 2022
The “breakthrough therapy” designation (BTD) is a recent mechanism implemented by the United States Food and Drug Administration (FDA) to expedite access to drugs that address unmet needs.
Megan C. Herink, Kirbee Johnston, Kristin Breninger, Erin Wu, Adriane N. Irwin   +4 more
doaj   +1 more source

Drugs and Devices

JACC: Basic to Translational Science, 2016
The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.
Gail A. Van Norman, MD
doaj   +1 more source

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

Revista Panamericana de Salud Pública, 2022
Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin ...
Ivar T. van der Zee, Rick A. Vreman, Lawrence Liberti, Mario Alanis Garza   +3 more
doaj   +1 more source

Product Complexity and Strategic Alliance on Drug Approval

American Business Review, 2021
Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped relationship between product complexity and the time to approval by the US Food and Drug Administration (FDA)
Taoyong Su , Wanrong Hou , Edward Levitas , Sibin Wu   +3 more
doaj   +1 more source

Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: a cross-sectional study

Journal of Pharmaceutical Policy and Practice, 2017
Background The WHO Model List of Essential Medicines for Children (EMLc) covers medicines for globally high-burden diseases. Regulatory approval in high-income countries ensures evidence and dosage form but usually focuses on diseases common in those ...
Rumiko Shimazawa, Masayuki Ikeda
doaj   +1 more source

Drugs, Devices, and the FDA: Part 1

JACC: Basic to Translational Science, 2016
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world.
Gail A. Van Norman, MD
doaj   +1 more source

Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration.

JAMA Oncology, 2019
Importance To date, an empirical evaluation of the quality of control arms in randomized clinical trials (RCTs) leading to anticancer drug approvals by the US Food and Drug Administration (FDA) has not been undertaken.
Talal Hilal, M. Sonbol, V. Prasad
semanticscholar   +1 more source