Results 271 to 280 of about 4,926,176 (337)

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

Drug Approval and Surveillance

International Journal of Gynecology & Obstetrics, 1980
ABSTRACTThe author proposes that current regulations governing the licensing of drugs, particularly in the United States, need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use.
openaire   +2 more sources

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

Tardive Dyskinesia Drug Approved

JAMA, 2017
The first drug for adults with tardive dyskinesia (TD) has received FDA approval. Tardive dyskinesia is a neurological disorder that causes repetitive, involuntary movements such as abnormal tongue and lip movements, cheek bulging, foot tapping, shoulder shrugging, and rocking and swaying movements.
openaire   +2 more sources

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

Drug Approvals

The Nurse Practitioner, 2007
Gary, Laustsen, Marcia, Gilbert, Lynn, Wimett   +2 more
openaire   +3 more sources

2009 FDA drug approvals

Nature Reviews Drug Discovery, 2010
In a year in which regulators and drug companies gained familiarity with risk management strategies, the number of new drug approvals was similar to that in 2008.
openaire   +2 more sources

2014 FDA drug approvals

Nature Reviews Drug Discovery, 2015
The FDA approved 41 new therapeutics in 2014, but the bumper year fell short of the commercial power of the drugs approved in 2013.
openaire   +2 more sources

Real-world evidence and regulatory drug approval

Nature Reviews Clinical Oncology, 2020
M. Raphael, B. Gyawali, C. Booth
semanticscholar   +1 more source