Results 1 to 10 of about 4,852,148 (299)

An Analysis of New Drug Examination and Approval System of PRC

, 2008
Xiaopu Sun
openalex   +1 more source

The U.S. Drug Approval Process: A Primer

, 2001
Blanchard Randall
openalex   +1 more source

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.

JAMA Oncology, 2022
Importance Single-arm trials have allowed for transformative therapies to be made available to patients expeditiously. However, using single-arm trials to support drug approval presents several challenges that must be carefully considered ...
S. Agrawal, Shaily Arora, L. Amiri-Kordestani, R. A. de Claro, L. Fashoyin-Aje, N. Gormley, Tamy Kim, S. Lemery, Gautam U. Mehta, E. Scott, H. Singh, Shenghui Tang, M. Theoret, R. Pazdur, P. Kluetz, J. Beaver   +15 more
semanticscholar   +1 more source

Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease.

Journal of Crohn's & Colitis, 2021
BACKGROUND AND AIMS Timely access to approved medications is a priority in paediatric inflammatory bowel disease (IBD). To date, the timing of drug studies in paediatric IBD has been suboptimal with most studies conducted long after approval has been ...
E. Crowley, Christopher Ma, Marija Andic, B. Feagan, A. Griffiths, V. Jairath   +5 more
semanticscholar   +1 more source

Overall Survival, Progression-Free Survival, and Tumor Response Benefit Supporting Initial US Food and Drug Administration Approval and Indication Extension of New Cancer Drugs, 2003-2021

Journal of Clinical Oncology, 2022
PURPOSE Clinical trial evidence is routinely evaluated for initial drug approvals, yet the benefit of indication extensions remains uncertain. This study evaluates the clinical benefit supporting new cancer drugs' initial and supplemental US Food and ...
D. Michaeli, T. Michaeli
semanticscholar   +1 more source

Flexible Drug Approval Policies

Manufacturing & Service Operations Management, 2018
Problem definition: To approve a novel drug therapy, the U.S. Food and Drug Administration (FDA) requires clinical trial evidence demonstrating efficacy with 2.5% statistical significance, although the agency often uses regulatory discretion when ...
Fernanda Bravo, Taylor C. Corcoran, Elisa F. Long   +2 more
semanticscholar   +1 more source

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review

JAMA Oncology, 2018
Importance Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or ...
J. Beaver, L. Howie, Lorraine C Pelosof, Tamy Kim, Jinzhong Liu, Kirsten B. Goldberg, R. Sridhara, G. Blumenthal, A. Farrell, P. Keegan, R. Pazdur, P. Kluetz   +11 more
semanticscholar   +1 more source

Characteristics of expedited programmes for cancer drug approval in China

Nature reviews. Drug discovery, 2021
Guanqiao Li, Yang Liu, Cuicui Xie, Qing Zhou, Xiaoyuan Chen   +4 more
semanticscholar   +1 more source

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

Journal of Clinical Oncology, 2018
Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non-breakthrough-designated cancer drugs ...
T. Hwang, J. Franklin, Christopher T Chen, J. Lauffenburger, B. Gyawali, A. Kesselheim, Jonathan J. Darrow   +6 more
semanticscholar   +1 more source