scholarly journals FAST TRACK USA REGULATORY APPROVAL FOR DRUGS TO TREAT EMERGING INFECTIOUS DISEASES

Author(s):  
PAVITHRA GM ◽  
SABA MAANVIZHI

The Food and Drug Administration has established fast track approval to speed the designation of drugs that efficiently treat serious conditions, in particular those that provide improved advantages over available therapy. Fast track designation was initiated to curtail the time period in the new drug approval procedure and to promote the drug discovery and commercialization of drug products for critical and life-threatening illness and expedite the approval of drug products demonstrating advanced efficacy toward the prevailing one. Single Phase II study is reviewed before approving the drug within fast track designation. This review article highlights the consequences, criteria for fast track designation, fast track designation process, and the timeline for fast track approval.

1987 ◽  
Vol 32 (10) ◽  
pp. 906-906
Author(s):  
No authorship indicated

2013 ◽  
Author(s):  
Lawrence G. Calhoun ◽  
◽  
Jay Azarow ◽  
Tzipi Weiss ◽  
Joel Millam

2008 ◽  
Vol 5 (1) ◽  
pp. 81-88
Author(s):  
Philip Berry

When life-threatening illness robs a patient of the ability to express their desires, medical personnel must work through the issues of management and prognosis with relatives. Management decisions are guided by medical judgement and the relatives’ account of the patient’s wishes, but difficulties occur when distance grows between these two factors. In these circumstances the counselling process may turn into a doctor-led justification of the medical decision. This article presents two strands of dialogue, in which a doctor, counselling for and against continuation of supportive treatment in two patients with liver failure, demonstrates selectivity and inconsistency in constructing an argument. The specific issues of loss of consciousness (with obscuration of personal identity), statistical ‘futility’ and removal of autonomy are explored and used to bolster diametrically opposed medical decisions. By examining the doctor’s ability to interpret these issues according to circumstance, the author demonstrates how it is possible to shade medical facts depending on the desired outcome.


2019 ◽  
Vol 18 (1) ◽  
Author(s):  
S. Robin Cohen ◽  
Lara B. Russell ◽  
Anne Leis ◽  
Javad Shahidi ◽  
Pat Porterfield ◽  
...  

Abstract Background Domains other than those commonly measured (physical, psychological, social, and sometimes existential/spiritual) are important to the quality of life of people with life-threatening illness. The McGill Quality of Life Questionnaire (MQOL) – Revised measures the four common domains. The aim of this study was to create a psychometrically sound instrument, MQOL – Expanded, to comprehensively measure quality of life by adding to MQOL-Revised the domains of cognition, healthcare, environment, (feeling like a) burden, and possibly, finance. Methods Confirmatory factor analyses were conducted on three datasets to ascertain whether seven new items belonged with existing MQOL-Revised domains, whether good model fit was obtained with their addition as five separate domains to MQOL-Revised, and whether a second-order factor representing overall quality of life was present. People with life-threatening illnesses (mainly cancer) or aged > 80 were recruited from 15 healthcare sites in seven Canadian provinces. Settings included: palliative home care and inpatient units; acute care units; oncology outpatient clinics. Results Good model fit was obtained when adding each of the five domains separately to MQOL-Revised and for the nine correlated domains. Fit was acceptable for a second-order factor model. The financial domain was removed because of low importance. The resulting MQOL-Expanded is a 21-item instrument with eight domains (fit of eight correlated domains: Comparative Fit Index = .96; Root Mean Square Error of Approximation = .033). Conclusions MQOL-Expanded builds on MQOL-Revised to more comprehensively measure the quality of life of people with life-threatening illness. Our analyses provide validity evidence for the MQOL-Expanded domain and summary scores; the need for further validation research is discussed. Use of MQOL-Expanded will enable a more holistic understanding of the quality of life of people with a life-threatening illness and the impact of treatments and interventions upon it. It will allow for a better understanding of less commonly assessed but important life domains (cognition, healthcare, environment, feeling like a burden) and their relationship to the more commonly assessed domains (physical, psychological, social, existential/spiritual).


2014 ◽  
Vol 23 (2) ◽  
pp. 176-179 ◽  
Author(s):  
Nishant Gupta ◽  
Stephen M. Kralovic ◽  
Dennis McGraw

Lemierre syndrome is a rare and life-threatening illness. Often referred to as “the forgotten disease,” its incidence is reported to be as low as 1 in a million. The microorganism responsible for Lemierre syndrome is typically Fusobacterium necrophorum. The bacterium starts in the pharynx and peritonsillar tissue, then disseminates through lymphatic vessels. Severe sepsis rapidly develops, as does the hallmark of this syndrome: septic thrombophlebitis of the internal jugular vein. This report describes a case of Lemierre syndrome in a previously healthy 26-year-old man with life-threatening internal jugular vein thrombophlebitis following 2 weeks of an indolent course of pharyngitis. The patient’s initial presentation and extensive travel history as an Army veteran were particularly challenging aspects in establishing his diagnosis. The diagnosis of Lemierre syndrome is frequently delayed. Routine use of bedside ultrasonography may aid in rapid diagnosis of the disease.


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