نتایج جستجو برای: united states food and drug administration

تعداد نتایج: 17009320  

Journal: :Women's health issues : official publication of the Jacobs Institute of Women's Health 2009
Ellen Pinnow Pellavi Sharma Ameeta Parekh Natalie Gevorkian Kathleen Uhl

BACKGROUND Historically women were excluded from participation in phase 1 clinical trials. The goal of this study was to determine the participation of women and evaluate if participation has increased over time. METHODS Clinical trial data submitted to the FDA for New Molecular Entities (NMEs) for adult, non-sex specific indications between January 2006 and December 2007 were reviewed. Elect...

Journal: :P & T : a peer-reviewed journal for formulary management 2017
Stephen Barlas

FDA pleases no one with final guidance on biological and biosimilar naming.

Journal: :P & T : a peer-reviewed journal for formulary management 2012
Stephen Barlas

Drug companies may be required to report shortages sooner, but the FDA legislation still lacks power.

Journal: :P & T : a peer-reviewed journal for formulary management 2018
Stephen Barlas

The Food and Drug Administration has made significant progress implementing some of the 60 provisions of the 21st Century Cures Act passed in 2016. The author discusses the successes and shortcomings of the agency's regulatory activities.

2017
H Scheerens A Malong K Bassett Z Boyd V Gupta J Harris C Mesick S Simnett H Stevens H Gilbert P Risser R Kalamegham J Jordan J Engel S Chen L Essioux JA Williams

US Food and Drug Administration (FDA)-approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This...

Journal: :International journal of health services : planning, administration, evaluation 2011
Michael Givel

Since the 1950s, despite considerable and long-term tobacco industry and government efforts, attempts to develop a less risky cigarette that reduces harmful ingredients, generally or specifically, have failed. Moreover, even under ideal conditions with adequate scientific testing, the efficacy of purportedly reducing the severe health effects cannot be scientifically verified for up to 20 years...

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